BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 17949815 · Received October 17, 2023

    Report

    Report Number
    9618003-2023-07825
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Report Date
    September 26, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    UDI-DI
    00768455150878
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT CITY: (B)(6). COMPLAINANT STATE: (B)(6). COMPLAINANT COUNTRY: (B)(6). NAME OF AFFILIATION: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. RETURNED SAMPLE EVALUATION: PHOTOS ASSOCIATED WITH THIS CASE WERE RECEIVED FOR EVALUATION. BATCH RECORD REVIEW: THE LOT 2A02779 WAS MANUFACTURED ON 16/JAN/2022 DOYEN B MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKU). COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 09/OCT/2023, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT. SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1704770 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. INVESTIGATION CONCLUSION: ROOT CAUSE(S): AFTER BRAINSTORMING AND ISHIKAWA, POTENTIAL ROOT CAUSE TO THE FAILURE MODE WAS IDENTIFIED. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN FOR EACH OF THE CAUSES IDENTIFY FOR PROBLEM SOLUTION. ROOT CAUSE(S): METHOD: DIRTY CARTS TO TRANSPORT MATERIALS. DIRTY TRAYS. METHOD: MIXERS WITH RESIDUES FROM PREVIOUS MIXTURES. MANPOWER: INADEQUATE TRANSFER OF MATERIALS. MANPOWER: INADEQUATE ELECTROCUTING LAMP MAINTENANCE. ACTIONS WERE TAKEN THROUGH CAPA (CORRECTIVE ACTION / PREVENTIVE ACTIONS) RECORD IN DATABASE. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT RECORD HAS BEEN APPROVED AND WAS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. 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: 9618003.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED THAT A BLACK STAIN WAS FOUND ON THE IMMEDIATE CONTAINER BUT IT CAN BE SEEN THAT IT PENETRATED INSIDE. FURTHERMORE. IT WAS CLARIFIED THAT THE INTERIOR STAIN WAS CAUSED BY THE EXTERIOR STAIN. 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
    90487 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187961 2A02779 00768455150878

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown