BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 16635001 · Received March 29, 2023

    Report

    Report Number
    1000317571-2023-00049
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 1, 2023
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT COUNTRY: JAPAN. 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. FDA REGISTRATION NUMBER. REPORTING SITE: 1049092. MANUFACTURING SITE: 1000317571.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY H6: IMDRF CAUSE CONCLUSIONS CODE - SINCE IT WAS MENTIONED THAT FOR THIS COMPLAINT WHICH WAS RECEIVED FOR GEL TUBES THAT REQUIRE SUPPLIER INVESTIGATION WILL BE UNABLE TO PROGRESS, IDENTIFY ISSUES OR RESUPPLY. HENCE, DETAILED AND IN-DEPTH INVESTIGATION WAS NOT PERFORMED AND THEREFORE, D17 IS SELECTED. A BATCH RECORD REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. GRANUGEL H/GEL W/NOZZLE 15G(1X10)STER JP WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) MATERIAL CODE 1100164 AND MANUFACTURING LOT NUMBER 1K00727 ON 23 NOVEMBER 2021. LOT # 1K00727 WAS STERILIZED UNDER BAXTER G.R. NUMBER 21K02K5707 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY BAXTERS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 1K00727. ONE NONCONFORMITY WAS OPENED AS A RESULT OF A THIRD-PARTY NON-CONFORMANCE (NC) RECEIVED AGAINST THE BATCH FOR AN INCORRECT GS1 BARCODE LABELLING BUT WAS NOT RELATED TO THIS ISSUE. THIS WAS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. THREE PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE PHOTOGRAPHS CONFIRM THE EXPECTED LOT NUMBER, PRODUCT AND THE COMPLAINT ISSUE WHERE THE METAL OPENING OF THE TUBE WAS OPENED IN A CRESCENT SHAPE AROUND THE EDGE OF THE METAL OPENING COVER. A NONCONFORMANCE WAS NOT OPENED FOR THIS COMPLAINT ISSUE, AS THE METAL TUBES FOR THE GEL PRODUCT WAS SUPPLIED BY AN EXTERNAL SUPPLIER AND IS NOT IMPACT. THE SUPPLIED MATERIAL (1026133C2) WAS SUPPLIED ON BATCH 1090640945 FROM SUPPLIER PHARMATUBE. ORDINARILY, A SCAR (SUPPLIER CORRECTIVE ACTION REPORT) WOULD BE RAISED FOR SUPPLIER PHARMATUBE, BUT SHORTLY AFTER THIS COMPLAINT WAS RECEIVED, PHARMATUBE ANNOUNCED THAT THEY HAD FALLEN INTO ADMINISTRATION. AS SUCH, THE RESOLUTION OF THIS ISSUE WITH THE SUPPLIER WAS NOT POSSIBLE AS THEY ARE CEASING TRADING AND WOULD BE UNABLE TO INVESTIGATE, IDENTIFY ISSUES OR RESUPPLY. SIMILAR ISSUES RELATING TO THE QUALITY OF THE GEL TUBES THEMSELVES ARE ALSO NOT POSSIBLE TO BE RESOLVED. A NEW SUPPLIER FOR THE GEL TUBES IS BEING SOURCED. AS NO FURTHER INVESTIGATION IS POSSIBLE, THE COMPLAINT INVESTIGATION WILL BE CLOSED. ANY FURTHER COMPLAINTS RECEIVED FOR THE GEL TUBES THAT REQUIRE SUPPLIER INVESTIGATION WILL BE UNABLE TO PROGRESS. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 1000317571.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE LID ON THE (B)(6), THE ENTRANCE WAS NOT SEALED. ALSO, THE LEAKED GEL HAD TURNED YELLOW. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910058 DUODERM PASTE AND GELS DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 401802 1K00727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown