FIELD CORRECTIVE ACTION LISTING FOR MAY 2024
The list below contains Medical Device’s Field Corrective Action for the month of May 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 |
03/05/2024 |
AUTOCAT 3 |
MDA/FCA/P0780-87733439-2024 |
GD877091305219 |
SCHRENK CHARLES THOMAS |
|
|
2 |
03/05/2024 |
AUTOCAT 3 |
MDA/FCA/P0782-56685862-2024 |
GD9475223-139423 |
SCHRENK CHARLES THOMAS |
|
|
3 |
03/05/2024 |
ARROW AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM |
MDA/FCA/P0783-84495139-2024 |
GD44414701118 |
SCHRENK CHARLES THOMAS |
|
|
4 |
09/05/2024 |
GETINGE FLOW-I ANESTHESIA SYSTEM |
MDA/FCA/P0780-89749173-2024 |
GC25644700318 |
LIM WOON SUN |
|
|
5 |
09/05/2024 |
HEMODYNAMIC APPLICATION |
MDA/FCA/P0787-87003714-2024 |
GB685291134018 |
CHAN JIN HOE |
|
|
6 |
09/05/2024 |
Design update to the Model 8780, 8781 and 8784 Ascenda Intrathecal Catheters (Ascenda Catheter) |
SYNCHROMED II PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES |
MDA/FCA/P0791-53584752-2024 |
GD6185822-96376 |
YAM KIN HUNG |
|
7 |
10/05/2024 |
REAL INTELLIGENCE CORI |
MDA/FCA/P0792-63094108-2024 |
GB8636421-71478 |
CHEAM YOKE CHENG |
|
|
8 |
11/05/2024 |
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
MDA/FCA/P0789-81524008-2024 |
GD4151721-74880 |
YUMITRA A/P DHORAI RAJA |
|
|
9 |
14/05/2024 |
VITROS CHEMISTRY PRODUCTS ENZYMES |
MDA/FCA/P0795-64711289-2024 |
IVDB7737323-151303 |
MENG TSE LEEAU |
|
|
10 |
15/05/2024 |
Replacement workflow with DBS Pocket Adaptor affecting MRI eligibility display |
ACTIVA NEUROSTIMULATOR FOR DEEP BRAIN STIMULATION SYSTEM |
MDA/FCA/P0799-56887119-2024 |
GD9997822-89709 |
YAM KIN HUNG |
|
11 |
16/05/2023 |
INGENIA 1.5T, INGENIA 3.0T |
MDA/FCA/P0798 50059811-2024 |
GB63162332517 |
CHAN JIN HOE |
|
|
12 |
16/05/2023 |
DRAEGER FULL FACE MASK NON-INVASIVE VENTILATION FACE MASKS |
MDA/FCA/P0800-43591563-2024 |
GB7642222-99649 |
LESLIE LIEW WAI CHONG |
|
|
13 |
16/05/2024 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS |
MDA/FCA/P0801-38285635-2024 |
IVDD4213821-64864 |
MENG TSE LEEAU |
|
|
14 |
24/05/2024 |
Incorrect Expiration Date Assigned to VITROS® Chemistry Products Calibrator Kit 29, Lot 2953 |
VITROS IMMUNOCHEMISTRY ANEMIA |
MDA/FCA/P0808-24838188-2024 |
IVDB7591723-145140 |
MENG TSE LEEAU |
|
15 |
24/05/2024 |
CENTRICITY HIGH ACUITY ANESTHESIA |
MDA/FCA/P0810-56281422-2024 |
GMD29146275517A |
LIM SOCK SIANG |
|
|
16 |
27/05/2024 |
MOBILE DIAGNOST WDR |
MDA/FCA/P0804-83721267-2024 |
GC94902489117 |
CHAN JIN HOE |
|
|
17 |
27/05/2024 |
VITEK® 2 - AST Test Kits Incorrect Ceftriaxone Concentrations |
VITEK® 2 ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) CARD |
MDA/FCA/P0812-89961089-2024 |
IVDB7784623-128365 |
MICHAEL CONLON |
|
18 |
27/05/2024 |
BIOFIRE FILMARRAY INSTRUMENTS |
MDA/FCA/P0813-18352663-2024 |
IVDB8826823-128366 |
MICHAEL CONLON |
