FIELD CORRECTIVE ACTION (FCA) LISTING FOR NOVEMBER 2022

The list below contains Medical Device’s Field Corrective Action for the month of November 2022. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –

The return of the medical device to the establishment;
Modification of the medical device;
Exchange of the medical device;
Destruction of medical device; or
Specific advice on the use of the medical device.

If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.

Date received	Title of FCA	Affected Medical Device	MDA Reference Number	MDA Registration Number	Description	Local Establishment Contact Detail
23 Nov 2022	Follow Up Communication to Assurity & Endurity Laser Adhesion Field Safety Corrective Action (FA-Q322-CRM-1)	ASSURITY & ASSURITY MRI PACEMAKERS	MDA/FCA/P0135-91376142-2022	GD71875822118	Abbott is providing the following supplemental information for consideration by clinicians in determining the appropriate course of action for patients: 1. The observed average time to functionality interruption at present is 2.2 years post implant 2. There is a high degree of statistical confidence (95%) that, if a malfunction were to occur, 99% of devices will present functionality interruption at or after 1.44 years (526 days)	LAW CHING YEE REGULATORY AFFAIRS & COMPLIANCE MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD.
1 Nov 2022	FIELD SAFETY NOTICE – BD Trucount™ Tubes and Kits [BDB-22-4547]	BLOOD CELL COUNT IVD KIT AND CONTROLS	MDA/FCA/P0115-27849456-2022	IVDB71229158618	BD has confirmed through internal investigation that the labels applied to the BD Trucount™ tubes are becoming detached. Our investigation has identified an adhesive change made at a supplier resulting in the inadequate adhesion. BD is working closely with the supplier to resolve this situation expediently.	NUR AZALEA BINTI MUHAMMAD ZAINAL ASHIKIN REGULATORY AFFAIRS EXECUTIVE BECTON DICKINSON SDN BHD
30 Nov 2022	Field Corrective Action Alpha Active System	ALPHA ACTIVE PUMP SYSTEM	MDA/FCA/P0126-73039459-2022	GMD95507674218A	Arjo has investigated customer complaints where mains cables have been damaged accidently or through miss-use (i.e. incorrectly stowed). Although the mains cables on the Alpha Active models listed have been tested to, and comply with IEC60601-1 Medical electrical equipment	CHONG WAI MUN GENERAL MANAGER BEST CONTACT (M) SDN BHD
23 Nov 2022	Polaris Multimedia - Potentially Missing Securing Element	POLARIS MULTIMEDIA	MDA/FCA/P0121-70251695-2022	GA8379220-38340	During the course of our global market surveillance activities, we have become aware of a case in which the swivel arm of a display dropped from a ceiling tube, whereby it was held in place by internal cabling only.	BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD
16 Nov 2022	B105P/B125P (B1x5P) and B105M/B125M/B155M (B1x5M) patient monitors can display an inaccurate CO2 value when using a gas E-module for CO2 measurement in “mmHg” or “kPa” units when used at locations not at or near sea level.	B105P/B105M/B125P/ B125M/B155M PATIENT MONITOR	MDA/FCA/P0125-91190092-2022	GC3218021-63208	GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.	LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD
29 Nov 2022	NEONATAL, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M	NASAL CANNULA	MDA/FCA/P0142-30077767-2022	GB720571225118	Manufacturer have received reports from their side related to disconnection of the tube from the nasal prong section while using the Neonatal Nasal Cannula with curved prongs and tube.	CHEANG WAI SHAN SALES MANAGER KL MED SUPPLIES (M) SDN BHD
25 Nov 2022	FSCA Oncentra Brachy	FLEXITRON	MDA/FCA/P0139-54017271-2022	GC3716519-29208	In a rare situation, a reconstruction error may be introduced by Oncentra® Brachy to an existing catheter reconstruction, when using the catheter bending functionality. Erroneously placed reconstruction points may be added that create a double kink in the reconstruction	BHARAT KUMAR A/L VRAJLAL PREMCHAND DIRECTOR NYPRAX BUSINESS SOLUTIONS
25 Nov 2022	A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling	MICROSELECTRON	MDA/FCA/P0140-46624467-2022	GC55111585618	In a rare situation, a reconstruction error may be introduced by Oncentra® Brachy to an existing catheter reconstruction, when using the catheter bending functionality. Erroneously placed reconstruction points may be added that create a double kink in the reconstruction	BHARAT KUMAR A/L VRAJLAL PREMCHAND DIRECTOR NYPRAX BUSINESS SOLUTIONS
22 Nov 2022	M5071A Adult and M5072A Infant/child pads cartridges for use with HS1/OnSite/Home AEDs may experience gel separation and reduction of gel surface area	HEARTSTART HS1	MDA/FCA/P0132-45527431-2022	GC78411544718	Some electrode pads used with the HS1/OnSite/Home AED have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself, resulting in reduced surface area of gel on the pad.	ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD
23 Nov 2022	Ingenia Elition X, Ingenia Elition S, SmartPath to Ingenia Elition X, MR 7700 and ‘Upgrade to MR 7700’ Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	INGENIA ELITION	MDA/FCA/P0136-65349717-2022	GB179941251719	Philips has identified an issue where a specific component failure in the Gradient Coil of where the Affected 3T MR Systems identified in this letter may act as a heat source, with a potential to produce smoke and/or fire.	ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD
23 Nov 2022	Philips Fetal Spiral Electrode Needle Tip Breaking	AVALON FETAL MONITORS	MDA/FCA/P0138-97367458-2022	GC95268545118	Philips has found that the spiral tip of the FSE may break off during use, potentially requiring surgical intervention to remove the broken tip from the patient.	ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD
9 Nov 2022	Elecsys CA 19-9: non-reproducible elevated results with certain reagent lots on cobas e 801 and e 402	ELECSYS CA 19-9	MDA/FCA/P0123-32422256-2022	IVDC53289203518	As described in the former versions of MY-FSN-CPS-2020-001, certain Elecsys CA 19-9 lots on cobas e 801 showed in internal investigations and/or customer complaints, an increased rate of non-reproducible elevated results.	KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD.
22 Nov 2022	Unacceptable Light Staining & review of negative results - VENTANA PD-L1 (SP142) Assay Specific Lots	VENTANA PD-L1 (SP142) ASSAY	MDA/FCA/P0133-31318786-2022	IVDC77381365919	VENTANA Medical Systems, Inc. (Roche) observed unacceptable, light staining with some VENTANA PD-L1 (SP142) on-market lots, during internal comparison studies.	KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD.
17 Nov 2022	Multiple issues concerning VD12A systems Sensis or Sensis Vibe AX057/22/S, AX058/22/S (FSCA), AX059/22/S (FSN)	SENSIS VIBE	MDA/FCA/P0128-86684882-2022	GC26491801918	Issue 1: “PASSWORD STORE CORRUPTED” error message during system bootup Issue 2: Subsystem crash during examination Issue 3: Dialog Monitor Computer (DMC) application crash while loading a study Issue 4: Software crash due to system internal timeout	LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD
24 Nov 2022	XP051/22/S Potential risk of foot rest detaching from the patient table	LUMINOS AGILE MAX	MDA/FCA/P0130-84935675-2022	GC74703683318	The CSAN is distributed to inform about a preventive measure to exclude any potential risk of patient injury caused by the foot rest detaching from the patient table during an examination.	LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD
22 Nov 2022	Intra-Aortic Balloon Pump (IABP), Short Battery Run Times - Advisory Notice	ARROW AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM	MDA/FCA/P0134-78584935-2022	GD44414701118	Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run‐times on the affected intra‐aortic balloon pump (IABP) devices.	CHUAH SIEW SEE REGULATORY AFFAIRS MANAGER TELEFLEX MEDICAL SDN.BHD
23 Nov 2022	Intra-Aortic Balloon Pump (IABP), Short Battery Run Times - Advisory Notice	AUTOCAT 3	MDA/FCA/P0137-69993396-2022	GD877091305219	Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run‐times on the affected intra‐aortic balloon pump (IABP) devices.	CHUAH SIEW SEE REGULATORY AFFAIRS MANAGER TELEFLEX MEDICAL SDN.BHD