BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 10098704 · Received May 28, 2020

    Report

    Report Number
    1000317571-2020-00011
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT (B)(4) STATES: SECUREMENT ISSUES AND VISUAL ISSUE THE PRODUCT IS A DIFFERENT COLOUR THAN EXPECTED. A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PREVENTIVE MAINTENANCE (PM) LOGS HAVE BEEN CHECKED AND ALL PM'S WERE COMPLETED. AFFECTED AMOUNT: 1PC. DUODERM H/ACTIVE GEL (3X30G) WAS MANUFACTURED UNDER SYSTEM APPLICATION AND PRODUCTS (SAP) CODE 1002859 AND MANUFACTURING LOT NUMBER 9F01959. LOT NUMBER 9F01959 WAS STERILIZED UNDER LOTS 19F24K6096 AND 19F24K6098 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION. ALL THE RESULTS WERE WITHIN SPECIFICATION AND THE PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PROCESS INSTRUCTIONS (PI) FOR GEL. A VISUAL INSPECTION WAS PERFORMED IN ACCORDANCE WITH BATCH RECORD (BR)COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY FIFTEEN (15) MINUTES FOLLOWING UNTIL THE ORDER WAS COMPLETED. NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT 9F01959. THERE ARE TWO (2) COMPLAINTS REGISTERED FOR THE AFFECTED LOT IN THE COMPLAINT HANDLING SYSTEM (TW) FOR DIFFERENT MALFUNCTIONS. TWO (2) PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS COMPLAINT ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE PHOTOGRAPHS CONFIRM THAT THIS IS A CONVATEC PRODUCT AND CONFIRMS THE COMPLAINT ISSUE. THE ISSUE IS THAT THE CAP RING IS MISSING ON THE TUBE WHICH IS SUPPLIED BY A SUPPLIER AND IT IS FILLED FROM THE CRIMP END. IF THE CAP RING IS MISSING THIS MEANS THAT THE CAP MAY BE WOUND ONTO THE TUBE FURTHER THAN NORMAL WHEN THE TUBE IS MANUFACTURED AT THE SUPPLIER. OPERATORS HAVE BEEN MADE AWARE OF THE COMPLAINT ISSUE FOR HAND PACKING THE TUBES TO ENSURE THE CAP RING IS THERE. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "WHEN REMOVING THE CAP, THE SECURITY SEAL OF THE TUBE WAS ALREADY BROKEN." THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559221 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 9F01959

    Patients

    Seq Age Sex Outcome Treatment
    1