BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 18632304 · Received February 2, 2024

    Report

    Report Number
    1000317571-2024-00007
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 10, 2024
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    UDI-DI
    00768455172979
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    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. A BATCH RECORD REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. DUODERM H/ACTIVE GEL (3TBEX30G) STER US WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1002859 AND MANUFACTURING LOT NUMBER 3G03366 ON 09 AUGUST 2023. SYSTEM APPLICATION PRODUCT (SAP) STATES THE MANUFACTURE DATE AS 01 AUGUST 2023, BUT THE BATCH RECORD CONFIRMS THE MANUFACTURE DATE AS 09 AUGUST 2023. LOT # 3G03366 WAS STERILIZED UNDER ANDERSEN CALEDONIA BATCH SSP270723-1 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY ANDERSEN CALEDONIA. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 3G03366. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. SIX 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 A SPLIT IN THE METAL COVERING FOR THE TUBE OPENING IS SPLIT AND OPEN. LEAKED, WET GEL CAN BE SEEN WITHIN THE GEL LID. A NONCONFORMANCE WAS NOT OPENED FOR THIS COMPLAINT ISSUE, AS THE ALUMINIUM TUBES FOR THE GEL PRODUCT IS SUPPLIED BY AN EXTERNAL SUPPLIER. THE SUPPLIED MATERIAL (1024928G1) WAS SUPPLIED ON BATCH 1090640996 FROM SUPPLIER PHARMATUBE. ORDINARILY, A SCAR (SUPPLIER CORRECTIVE ACTION REPORT) WOULD BE RAISED FOR SUPPLIER PHARMATUBE, BUT PHARMATUBE ARE NO LONGER TRADING AND ARE IN ADMINISTRATION. AS SUCH, THE RESOLUTION OF THIS ISSUE WITH THE SUPPLIER IS 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 AND VALIDATED. 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. THE METAL COVERING FOR THE TUBE OPENING HAS BEEN SPLIT OPEN, EITHER PRIOR TO GEL FILL OR BY THE ACTION OF THE SPIKE ON THE INSIDE OF THE LID. BUT IN BOTH CASES, WOULD BE THE RESPONSIBILITY OF THE GEL TUBE MANUFACTURER AS THE TUBE, CAP AND COLLAR RING WERE PROVIDED BY THEM. DUE TO THE BREACH, THE PRODUCT WOULD NOT BE SAFE TO USE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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

    E1: COMPLAINANT STREET ADDRESS: (B)(6). COMPLAINANT COUNTRY: (B)(6). COMPLAINANT PHONE: (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. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 1000317571.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED THAT A CUSTOMER HAD NOTICED A HOLE IN COMPANY'S KNOWN TUBE. THE TUBE WAS LEAKING. IT WAS A NEW TUBE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348109 DUODERM PASTE AND GELS DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 3G03366 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown