BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0900 - AQUACEL AG

    MDR report key: 12195690 · Received July 20, 2021

    Report

    Report Number
    1000317571-2021-00201
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Report Date
    June 23, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    PMA / PMN Number
    K123481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1): CONTACT OFFICE ADDRESS: (B)(6). A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED. AFFECTED AMOUNT: 2PCS. AQUACEL FOAM AG N/ADH 10X10CM WAS MANUFACTURED UNDER SAP CODE (B)(4) AND MANUFACTURING LOT NUMBER 0K02850. LOT # 0K02850 WAS STERILISED UNDER LOT 2636793 AND RELEASED ON REVIEW OF RESULTS OF STERILISATION PROVIDED BY STERILISATION COMPANY STERIGENICS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-151 VER.35.0 FOR THE CIRCLE. VISUAL INSPECTION IN ACCORDANCE WITH TM-002 WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY 15 MINUTES FOLLOWING UNTIL THE ORDER WAS COMPLETE. NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT 0K02850 . TWO COMPLAINTS HAVE BEEN RECEIVED FOR THE AFFECTED LOT HOWEVER THEY ARE FOR DIFFERENT COMPLAINT ISSUES AND DIFFERENT MALFUNCTION CODES. NO PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS COMPLAINT. EVENT 1467145 HAS BEEN OPENED FOR THIS COMPLAINT ISSUE WITH INVESTIGATION 1468263. NO STOP SHIP WAS COMPLETED DUE TO NO STOCK BEING COMMERCIALLY AVAILABLE WITHIN CONVATEC'S CONTROL. AN HHE IS CURRENTLY UNDERWAY TO DETERMINE THE RISK TO PATIENTS. INVESTIGATION 1468263 HAS BEEN COMPLETED AND THE 2 POSSIBLE ROOT CAUSES (DUE TO NO PHOTOGRAPHS) HAVE BEEN FOUND TO BE: PRODUCT INCORRECTLY PLACED ONTO WEB AT INFEED, PACK SIDE NOT SEALED DUE TO PRODUCT IN SEAL AREA. PACK CUT BUT NOT SEALED ACROSS AT ONE SIDE DURING HOMING PROCEDURE AFTER RESTART OF MACHINE. THE FOLLOWING SOLUTIONS ARE ALREADY IN PLACE TO PREVENT THIS ISSUE FROM HAPPENING: NEW INSPECTION SYSTEM INSTALLED OUTSIDE OF THE CLEANROOM AND PACKS ARE 100% AUTOMATICALLY INSPECTED BY A CAMERA SYSTEM WITH ANY DEFECTS DIVERTED TO REJECT BEFORE BEING HAND PACKED INTO CARTONS. FIRST PACKS ARE REMOVED AFTER RE-START IN ACCORDANCE WITH SWI-CIRCLE-2014. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4); MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. COMPLAINANT CITY: (B)(6). PATIENT COUNTRY: (B)(6). CONTACT OFFICE ADDRESS: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PACKAGING WAS NOT PROPERLY SEALED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095278 L3W0900 - AQUACEL AG DRESSING, WOUND, DRUG FRO CONVATEC DOMINICAN REPUBLIC INC 420642 0K02850

    Patients

    Seq Age Sex Outcome Treatment
    1