BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 20050305 · Received August 23, 2024

    Report

    Report Number
    1000317571-2024-00066
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    July 29, 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: H4: DEVICE MANUFACTURE DATE. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: 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 3L01846 ON 01 DEC 2023. LOT # 3L01846 WAS STERILIZED UNDER ANDERSEN CALEDONIA BATCH SSP221123-1 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 3L01846. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. 3 PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTION (WI). THE PHOTOGRAPHS CONFIRM THE EXPECTED LOT, PRODUCT AND THE COMPLAINT ISSUE WHERE THE 2 OF 3 GEL TUBES EXHIBIT A HOLE/PIERCING AND A 3RD GEL TUBE WAS CRUMPLED AT THE CRIMPED END. THERE WAS EVIDENCE OF DRIED GEL WHERE THE HOLE/PIERCING WAS PRESENT ON ONE TUBE. A NONCONFORMANCE WAS NOT OPENED FOR THIS COMPLAINT ISSUE. AS PER PROCEDURE, ACCEPTABLE QUALITY LEVEL (AQL) IS IDENTIFIED AS 4.0 FOR PRIMARY PACK APPEARANCE OR 0.65 FOR CONTAMINATION. AS THE BATCH SIZE IS OVER 11637 PRIMARY UNITS, THE DOCUMENT STATES WE CAN ACCEPT 3 AND REJECT 4 UNITS WITH THIS ISSUE. AS NO FURTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS BATCH AND 3 UNITS ARE IDENTIFIED HERE, THE REJECT RATE HAS NOT BEEN MET. THE ALUMINUM TUBES USED IN THIS BATCH WOULD HAVE BEEN PROVIDED BY SUPPLIER PHARMA TUBE. AS IT IS UNLIKELY THAT THE TUBE COULD HAVE BEEN IN THIS CONDITION BEFORE FILLING, CONTACTING THE SUPPLIER WOULD NOT BE NECESSARY. THE SUPPLIER HAS SINCE CEASED TRADING, SO WOULD NOT BE POSSIBLE ANYWAY. SUPPLIER QUALITY AND DISTRIBUTION QUALITY WERE ASKED FOR COMMENT AND INSIGHT ON THE ISSUE. SUPPLIER QUALITY CONFIRM THAT THERE IS NOTHING WITHIN THE STERILIZATION PROCESS OR RELATED HANDLING THAT WOULD CAUSE PIERCINGS IN THE TUBE. GIVEN THE INCREASE IN PRESSURE DURING THE STERILIZATION PROCESS, IT IS LIKELY GEL WOULD HAVE EXUDED FROM THE TUBES IF THE HOLES WERE PRESENT BEFORE THE STERILIZATION PROCESS, SO THIS CAN BE RULED OUT. FOLLOWING STERILIZATION, THE MANUFACTURING TEAMS HAND PACK THE TUBES INTO THE SECONDARY CARTONS, SO IF THE TUBES WERE DAMAGED AT THIS POINT, IT IS MOST LIKELY THAT THE DAMAGED TUBES WOULD HAVE BEEN REJECTED BY THE HAND PACK OPERATORS. DISTRIBUTION QUALITY RULED OUT THE POSSIBILITY OF THE TUBES BEING DAMAGED DURING LOCAL RE-LABELLING PROCESSES. THE INSTRUCTIONS FOR USE (IFU) IS SLIPPED INTO THE SECONDARY CARTON WITHOUT OPENING IT, SO THERE IS NO HANDLING OF THE PRIMARY PACKS. THE LOCAL RE-LABELLING PROCEDURE FOR MALAYSIA SUGGESTS USE OF A FLAT NON-MARKING OBJECT LIKE A RULER TO AID INSERTION OF THE IFU, BUT THE LOCAL TEAMS STATE THERE WAS NO USE OF TOOLS DURING THE PROCESS FOR THIS BATCH. THE INVESTIGATION IS THEREFORE UNABLE TO CONCLUDE ROOT CAUSE OR WHERE THE PIERCING TO THE TUBES COULD HAVE OCCURRED. AS THE COMPLAINT DOESN¿T IDENTIFY THE STATE OF THE SECONDARY PACKAGING, IT IS NOT POSSIBLE TO SPECULATE FURTHER ON WHERE THE DAMAGE WAS SUSTAINED. 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.

    Additional Manufacturer Narrative · 0

    E1: (B)(6). DISTRIBUTOR'S NAME (FROM WHERE THE CUSTOMER REDWOOD PHARMA PURCHASED THE PRODUCT): DKSH. 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

    IT WAS REPORTED THAT THE CUSTOMER NOTICED THREE TUBES WERE DAMAGED AND TINY HOLE APPEARED ON THE SURFACE. THE PRODUCT WAS NOT USED. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312484 DUODERM PASTE AND GELS DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 3L01846 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown