BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 22684918 · Received August 1, 2025

    Report

    Report Number
    1000317571-2025-00083
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 7, 2025
    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 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. COMPLAINT WAS RECEIVED FROM MALAYSIA REPORTING ONE UNIT OF DUODERM H/ACTIVE GEL (3TBEX30G) WITH A BROKEN SEAL. THE AFFECTED LOT WAS 4K00378 (SYSTEM APPLICATION PRODUCT (SAP) 1002859), MANUFACTURED ON 27/NOV/2024 AND STERILIZED BY ANDERSON CALEDONIA UNDER CYCLES 04065¿04071 (COMPLETED 17/OCT/2024). BATCH SIZE: (B)(4) SECONDARY PACKS ((B)(4) PRIMARY). ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE EXPECTED PRODUCT AND LOT NUMBER WERE CONFIRMED. THE IMAGE SHOWED THAT THE COLLAR WAS REMOVED AND THE FOIL SEAL HAD BEEN BROKEN. FOR THIS DESIGN, THE COLLAR MUST BE REMOVED TO ALLOW THE CAP TO FULLY TIGHTEN AND BREAK THE INDUCTION SEAL. THIS STRONGLY INDICATES THAT THE TUBE WAS INTACT AT RELEASE AND THAT THE SEAL WAS SUBSEQUENTLY COMPROMISED AFTER DISTRIBUTION. NO PHYSICAL SAMPLE WAS RETURNED. A FULL BATCH RECORD REVIEW WAS COMPLETED FOR LOT: 4K00378. ALL IN-PROCESS INSPECTIONS, STAT SAMPLE CHECKS, AND FINAL RELEASE VERIFICATIONS WERE DOCUMENTED AS SATISFACTORY. NO DEVIATIONS, REWORK, OR NON-CONFORMANCE'S WERE RAISED FOR THIS BATCH. STERILIZATION RECORDS CONFIRMED ALL ACCEPTANCE CRITERIA WERE MET AND THE LOT WAS RELEASED BY ANDERSON CALEDONIA. A REVIEW OF THE TUBE AND CAP PRE-ASSEMBLY AND FILL PROCESS CONFIRMED THAT MULTIPLE OPERATOR AND AUTOMATED CHECKS ARE IN PLACE: SUPPLIER: ON RECEIPT OF TUBE + COLLAR + CAP ASSEMBLIES. AT CAP-TIGHTENING, WHERE OPERATORS VERIFY COLLAR PRESENCE AND CORRECT ENGAGEMENT. SECOND OPERATOR CHECK FOR CAP HEIGHT/FIT BEFORE TRANSPORT. CONVATEC GEL FILL: OPERATORS CONFIRM COLLAR/CAP BEFORE FILLING, TUBES PASS CAP-TIGHTENING STATION AND UPSIDE-DOWN DETECTOR, FOLLOWED BY IN-LINE CHECK WEIGH. POST-FILL: OPERATORS CHECK FOR LEAKS BEFORE PACKING INTO COREX BOXES. STERILIZATION: PRE- AND POST-CHECKS CONFIRM NO DAMAGED CAPS, LEAKS, OR BURST TUBES. ANY COMPROMISED SEAL WOULD HAVE FAILED STERILIZATION DUE TO HIGH TEMPERATURE/PRESSURE. CONVATEC SECONDARY PACKAGING AT DEESIDE: MANUAL HAND-PACK WITH OPERATOR VISUAL CHECKS, IN-PROCESS QA CHECKS, AND FINAL INSPECTION (COUNT, LABELS, EXPIRY, INSERTS, CONTAMINATION, SHIPPER INTEGRITY). TREND REVIEW: NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR LOT: 4K00378. A SEPARATE COMPLAINT WAS RECEIVED FOR LOT: 4G00418 WHERE THE COLLAR WAS STILL PRESENT, AGAIN SUGGESTING THE TUBE WAS INTACT AT RELEASE. NEITHER COMPLAINT DEMONSTRATES A SYSTEMIC TREND AT DEESIDE. RISK ASSESSMENT: THE ISSUE IS REGULATORY (OPEN SEAL INSIDE STERILE PACK), BUT ALL AVAILABLE EVIDENCE SHOWS THE UNIT WAS COMPLIANT AT MANUFACTURE AND STERILIZATION. THE PRESENCE/ABSENCE OF THE COLLAR IN THE PHOTOGRAPH WAS CONSISTENT WITH POST-DISTRIBUTION TAMPERING OR HANDLING AT THE DISTRIBUTION CENTRE. THE EVENT WAS ISOLATED AND DOES NOT INDICATE A PROCESS FAILURE AT DEESIDE. ACCORDING TO PROCESS INSTRUCTION (PI), THE ACCEPTABLE QUALITY LEVEL (AQL) FOR SEAL INTEGRITY OF PRIMARY PACKS IS 0.40 (ACCEPT 1, REJECT 2 FOR N=125). AT MANUFACTURE, LOT: 4K00378 WAS INSPECTED AGAINST THIS PLAN AND MET ACCEPTANCE CRITERIA. ONE UNIT AFFECTED POST-DISTRIBUTION OUT OF (B)(4) DOES NOT CONSTITUTE AN ACCEPTABLE QUALITY LEVEL (AQL) EXCURSION. CONCLUSION: THE COMPLAINT WAS CONFIRMED, BUT NO EVIDENCE SUPPORTS DEESIDE MANUFACTURING AS THE SOURCE. THE MOST LIKELY CAUSE WAS TAMPERING OR MISHANDLING AT THE DISTRIBUTION CENTRE OR IN THE FIELD. NO SYSTEMIC RISK WAS IDENTIFIED. IN ACCORDANCE WITH WORK INSTRUCTIONS (WI), CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) IS NOT REQUIRED. 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 STREET: (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

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A BROKEN SEAL. CUSTOMER NOTICED THAT THE SEAL ON ONE UNIT OF COMPANY'S GEL TUBE WAS BROKEN. THE BOX WAS INTACT. THE PRODUCT WAS NOT USED BY PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277663 DUODERM PASTE AND GELS DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 4K00378 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown