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FIELD CORRECTIVE ACTION LISTING FOR FEBRUARY 2024
The list below contains Medical Device’s Field Corrective Action for the month of February 2024. 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 |
Local Establishment Contact Detail |
|
1 |
01/02/ 2024 |
Possible overfilling of the humidifier due to incorrectly installed refill hose by the operator |
SOPHIE |
GC8951523-136057 |
KHO BENG TEIK |
|
|
2 |
01/02/2024 |
Potential hazard of device failure due to defective heater cable. |
SOPHIE |
GC8951523-136057 |
KHO BENG TEIK |
|
|
3 |
02/02/2024 |
Exchange of Transfer Set with possible leaking issue |
TRANSFER SET |
GA84078400417 |
NOOR IBTISYAM BINTI MOHAMAD ADNAN |
|
|
4 |
02/02/2024 |
Multiple Issues related to Software Anomalies for Field Safety Corrective Action FSCA-21-003 |
FABIAN NEONATAL / PEDIATRIC VENTILATORS |
GC92488887018 |
NOOR FAIZAH BINTI KAMARUDIN |
|
|
5 |
05/02/2024 |
BIOFIRE GI Panel - False Positive Norovirus Results |
FILMARRAY GASTROINTESTINAL PANEL |
IVDB8972220517 |
FRANCIS WONG CHIN HIN |
|
|
6 |
06/02/2024 |
Philips Azurion System Loss of function due to Certeray generator failure |
AZURION 7 |
GC82521235717 |
ZAM ZARINA BINTI MAT AIL |
|
|
7 |
06/02/2024 |
BIOFIRE PN PNplus FP Seasonal CoV Detections NP |
FILMARRAY PNEUMONIA PANEL |
IVDD8796819-29151 |
FRANCIS WONG CHIN HIN |
|
|
8 |
07/02/2024 |
POTENTIAL SAMPLE MISIDENTIFICATION MANDATORY SOFTWARE UPGRADE ACL TOP FAMILY 50 SERIES |
ACL TOP FAMILY |
IVDC8262823-138692 |
CHAI AI LIN |
|
|
9 |
15/02/2024 |
UIBC OSR61205 Post Launch Risk Assessment Mismatch Expiry Dates |
ANAEMIA |
IVDB10309423-125411 |
ONG NGUAN CHING |
|
|
10 |
15/02/2024 |
VisuMax, VISUMAX 600, VISUMAX 800 Preventive laser source replacement |
VISUMAX |
GC3815545416 |
YAP CHUN CHONG |
|
|
11 |
20/02/2024 |
BD BBL™ Sensi-Disc |
BD BBL™ SENSI-DISC™ SUSCEPTIBILITY TEST DISCS |
IVDB6578123-148932 |
LIM PUI SAN |
|
|
12 |
20/02/2024 |
HeartMate 3 Extrinsic Outflow Graft Obstruction |
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
GD2805621-62128 |
YUMITRA A/P DHORAI RAJA |
|
|
13 |
22/02/2024 |
New warning in Instructions for Use for Ambu® aView™ 2 Advance |
Ambu® aView™ 2 Advance |
GA7331121-51519 |
MARSHABILA BINTI MD NAZRI |
|
|
14 |
23/02/2024 |
HeartSine Samaritan PAD nipped cables |
SAMARITAN PAD 350P/360P/500P |
GC1448998616 |
UMA DEVI A/P SADHIWAN @ SADASIVAM |
|
|
15 |
23/02/2024 |
Access Substrate P/N 81906 bottles without labels. |
ACCESS AFP (300 TEST KIT) |
IVDC4572923-147705 |
ONG NGUAN CHING |
|
|
16 |
24/02/2024 |
Auto Suture™ Structural Balloon Trocar / Blunt Tip Trocar Potential for Seal to Disengage into Cavity |
AUTOSUTURE BLUNT TIP TROCAR |
GB72185514917 |
YAM KIN HUNG |
|
|
17 |
28/02/2024 |
Potential For Aspiration From Incorrect Sample Container During Sampling Centre Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems |
VITROS IMMUNODIAGNOSTIC PRODUCTS FERTILITY & PREGNANCY HORMONES & PROTEINS |
IVDB7258323-129195 |
MENG TSE LEEAU |
|
|
18 |
29/02/2024 |
Reminding to utilize the device in accordance with the Instructions For Use (IFU). |
ELECTROSURGICAL KNIFES |
GC43835501717 |
HIDEKI NAGAI |
|
|
19 |
29/02/2024 |
HFOV LIMITED PERFORMANCE |
MAQUET SERVO VENTILATION SYSTEM |
GC87295608718 |
LIM WOON SUN |
|
|
20 |
29/02/2024 |
Incorrect Diluent Lot in VITROS® Chemistry Products Performance Verifier Lots Q1174 and R1176 |
VITROS CHEMISTRY PRODUCTS CLINICAL CHEMISTRY SUBSTRATES |
IVDB3335223-146398 |
MENG TSE LEEAU |
|
|
21 |
29/02/2024 |
Viratrol (AT474543) QC Bias for HISCL HBsAg Assay |
HISCL HBSAG ASSAY KIT |
IVDD29527258018 |
CHEAH KIT YIN |
|
|
22 |
29/02/2024 |
EPOC Host, epoc® Blood Analysis System iQC Sample Delivery (E49) error limit conflicts with the measurement range of Calculated Bicarbonate (cHCO3-) |
EPOC BLOOD ANALYSIS SYSTEM |
IVDC7557621-75750 |
FRAZER RODERICK JOHN |
