BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 21033487 · Received December 30, 2024

    Report

    Report Number
    1000317571-2024-00094
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Report Date
    December 5, 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

    CORRECTION: H4: DEVICE MANUFACTURE DATE - IN INITIAL EMDR, THE MANUFACTURE DATE WAS ADDED AS 17 JULY 2023, BUT THE BATCH RECORD CONFIRMS THE MANUFACTURE DATE IS 18 JULY 2023. HENCE, IT HAS BEEN CORRECTED. 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 3G05220 ON 18 JULY 2023. SYSTEM APPLICATION PRODUCT (SAP) IDENTIFIES THE MANUFACTURE DATE AS 17 JULY, BUT THE BATCH RECORD CONFIRMS PACKING BEGAN ON 18 JULY 2023 AT 11.20AM. LOT # 3G05220 WAS STERILIZED UNDER ANDERSEN CALEDONIA BATCHES SSP110723-2 AND SSP110723-3 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 3G05220. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. 2 PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE PHOTOGRAPHS CONFIRM THE EXPECTED LOT AND PRODUCT. DAMAGE IS SEEN ON THE CRIMP END OF THE TUBE, BUT THERE IS NOT SUFFICIENT DETAIL IN THE PHOTO TO IDENTIFY IF THE TUBE IS SPLIT OR IF THE EXTERNAL LACQUER IS MISSING. THERE APPEARS TO BE NO EVIDENCE OF RUST AS DESCRIBED IN THE COMPLAINT, BUT AS THE TUBE IS MADE OF ALUMINUM, ANY YELLOWING WOULD LIKELY BE DRIED GEL OR TUBE LACQUER. A NONCONFORMANCE WAS NOT OPENED FOR THIS COMPLAINT ISSUE. AS PER PROCESS INSTRUCTION (PI), ACCEPTABLE QUALITY LEVEL (AQL) IS IDENTIFIED AS 4.0 FOR PRIMARY PACK APPEARANCE OR 0.65 FOR CONTAMINATION. AS THE BATCH SIZE IS 11595 PRIMARY UNITS, THE DOCUMENT STATES AN ACCEPT 3 AND REJECT 4 UNITS WITH A SAMPLE ON 315. AS NO FURTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS BATCH AND AS NO STOCK REMAINS IN DISTRIBUTION CENTER (DC), THIS ISSUE REMAINS BELOW ACCEPTABLE QUALITY LEVELS (AQLS). THE ALUMINUM TUBES USED IN THIS BATCH WOULD HAVE BEEN PROVIDED BY SUPPLIER (B)(4). AS THE DAMAGE TO THE TUBE IS LOCATED ON THE CRIMP, IT IS MOST LIKELY THE TUBE HAS BEEN DAMAGED AFTER IT HAS BEEN FILLED AND ASSEMBLED. AS THE TUBE WOULD NOT HAVE BEEN RECEIVED LIKE THIS FROM THE SUPPLIER, 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 DAMAGE OF THIS KIND TO THE TUBE. GIVEN THE INCREASE IN PRESSURE DURING THE STERILIZATION PROCESS, IT IS LIKELY GEL WOULD HAVE EXUDED FROM THE TUBES IF A PERFORATION WAS 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 TUBE WAS DAMAGED AT THIS POINT, IT IS MOST LIKELY THAT THE DAMAGED TUBE WOULD HAVE BEEN REJECTED BY THE HANDPICK OPERATORS. IT IS NOTED THAT THE GEL TUBE BEARS ADDITIONAL LOCAL LANGUAGE LABELS AND A PHARMACY PRICE LABEL NOT ADDED IN THE MANUFACTURE PROCESS. DISTRIBUTION QUALITY RULED OUT THE POSSIBILITY OF THE TUBES BEING DAMAGED DURING LOCAL RELABELING PROCESSES. FEEDBACK RECEIVED FROM THE DQ AND LOCAL QUALITY TEAM IDENTIFIED THE MOST LIKELY POINT AT WHICH THE GEL TUBE COULD BE DAMAGED IS AT THE POINT OF THE RETAILER¿S PRICE STICKER BEING ATTACHED TO THE TUBE OVER THE CRIMP AREA, SO IS MOST LIKELY TO HAVE OCCURRED OUTSIDE OF OUR COMPANY CONTROL AND AFTER DISTRIBUTION FROM OUR COMPANY CONTROLLED DCS. 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: COMPLAINANT INFORMATION: (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 RETAILER REPORTED THAT THE GEL TUBE WAS SPLIT, RUSTED AND PERFORATED. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437909 DUODERM PASTE AND GELS DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 3G05220 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown