FIELD CORRECTIVE ACTION LISTING FOR DECEMBER 2023

The list below contains Medical Device’s Field Corrective Action for the month of December 2023. 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.

No	Date received	Title of FCA	Affected Medical Device	MDA Reference Number	MDA Registration Number	Description	Local Establishment Contact Detail
1	12 Dec 2023	Urgent Field Safety Notice on Presence of Lubricants in the Vaginal Specimen may Interfere Actim® Partus Test Result	ALERE ACTIM PARTUS	MDA/FCA/P0612-36284740-2023	IVDB16716341018	Recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the Partus test result. The possible interference has not been stated in current instructions for use.	WINNIE HII LIN LIN SENIOR REGULATORY AFFAIRS SPECIALIST ABBOTT DIAGNOSTICS HEALTH SDN BHD
2	19 Dec 2023	Urgent Field Safety Notice on Presence of Lubricants in the Vaginal Specimen may Interfere Actim® PROM Test Result	ACTIM® PROM TEST	MDA/FCA/P0629-63815712-2023	IVDB48023332118	Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the PROM test result, which deviates from what is presented in instructions for use.	WINNIE HII LIN LIN SENIOR REGULATORY AFFAIRS SPECIALIST ABBOTT DIAGNOSTICS HEALTH SDN BHD
3	29 Dec 2023	GE HealthCare – Potential for elevated levels of Formaldehyde from EVair and EVair 03 (Jun-Air) Compressors when used with the CARESCAPE R860 or Engström Carestation/ Pro ventilators	CARESCAPE R860	MDA/FCA/P0642-75016512-2023	GC97483321017	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engström Carestation/ Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40C (104F), at the lowest possible flow condition of 2 L/min (worst-case, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen).	LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD
4	23 Dec 2023	Field Safety Notification for MEGADYNE™ MEGA SOFT™ Universal and Universal Plus Reusable Patient Return Electrodes	ELECTROSURGICAL SYSTEM	MDA/FCA/P0614-42120567-2023	GC2965522-109913	The purpose of this medical device notification is to communicate an important change to the intended use population (e.g., indications) for the MEGA SOFT™ Universal and Universal Plus Reusable Patient Return Electrodes (product codes: 0845, 0846, 0847, and 0848) to help ensure safe and effective use.	YAP KWAI LING REGULATORY AFFAIRS LEAD, MEDTECH JOHNSON & JOHNSON SDN BHD
5	21 Dec 2023	[CVG-21-Q3-21 Rev S and U] HVAD Pump Failure to Restart	HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD)	MDA/FCA/P0636-11042593-2023	GD74345985518	CAPA 502194 was initiated on 23-Jul-2020 due to the escalation of RPI IEDF00247. RPI IEDF00247’s scope includes complaints received on pumps failing to initially start, restart or experiencing a delay in restart within the maximum number of restart attempts per the software configuration (30 restart attempts), regardless of whether the pump ultimately restarted.	CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD
6	22 Dec 2023	StealthStation™ S7/i7 Cranial Software v3.1.1, 3.1.2, and 3.1.3, Biopsy Depth Gauge Cycle View Inaccuracy Software Update Fix Availability - Follow-up Communication	STEALTHSTATION S7 TREATMENT GUIDANCE SYSTEM (CRANIAL)	MDA/FCA/P0641-26011160-2023	GD5865623-131796	his FCA for software update of new Cranial Software (9735585), Version 3.1.5 to correct the potential for inaccuracy during biopsy procedures using the StealthStation™ S7 and i7 Biopsy Depth Gauge feature.	CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD
7	20 Dec 2023	Reinforcing the instructions for MAJ-2315 distal cover attachment and user verification of distal cover attachment.	EVIS EXERA III DUODENOVIDEOSCOPE TJF-Q190V	MDA/FCA/P0617-65322625-2023	GB4632321-70352	This Field Safety Notice is initiated after becoming aware that the Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use.	YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD.
8	15 Dec 2023	FSN 2023-IGT-BST-005 Azurion 3 Philips Azurion System 81.0, 81.1, 81.2, 82.0, R2.1, and R2.2 Potential loss of imaging functionality and clinical data stored in the system.	AZURION 3	MDA/FCA/P0617-80515884-2023	GC99381544218	If this issue occurs, the Philips Azurion system might not recover from this fault situation causing the system to not be available. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.	ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD
9	18 Dec 2023	010 CN PPC 24-01 N Antiserum to Human IgA and N Antiserum to Human IgM - Incorrect high-dose hook effect claim for the sensitive applications	N ANTISERUM TO HUMAN IGA	MDA/FCA/P0627-97405132-2023	IVDC3972923-114643	Siemens Healthcare Diagnostics Products GmbH has confirmed that the Instruction for Use (IFU) for N Antiserum to Human IgA and for N Antiserum to Human IgM might be misleading concerning that the reagents show no high-dose hook effect up to 58.6 g/L and 44.6 g/L respectively for the sensitive applications (IgAs, SAN 22 and IgMs, SAN 23).	LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD.
10	18 Dec 2023	010 CN PPC 24-01 N Antiserum to Human IgM - Incorrect high-dose hook effect claim for the sensitive applications	N ANTISERUM TO HUMAN IGM	MDA/FCA/P0628-19341860-2023	IVDC3764423-118238	Siemens Healthcare Diagnostics Products GmbH has confirmed that the Instruction for Use (IFU) for N Antiserum to Human IgA and for N Antiserum to Human IgM might be misleading concerning that the reagents show no high-dose hook effect up to 58.6 g/L and 44.6 g/L respectively for the sensitive applications (IgAs, SAN 22 and IgMs, SAN 23).	LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD.