BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 20178794 · Received September 10, 2024

    Report

    Report Number
    9618003-2024-02734
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Report Date
    August 16, 2024
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    UDI-DI
    00768455150939
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (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: 9618003.

    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 BATCH RECORD REVIEW: THE LOT 2K03536 WAS MANUFACTURED ON 31/OCT/2022, BODOLAY MANUFACTURING LINE, WITH A TOTAL OF 10,800 MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 27/SEP/2024, 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 1704769 AND MANUFACTURING ORDER 1654114. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WERE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE CONFIRMED. INVESTIGATION SUMMARY ROOT CAUSE (S): AS A RESULT OF THE INVESTIGATION, IN WHICH THE MULTIDISCIPLINARY TEAM PERFORMED A 5WHY EXERCISE TO IDENTIFY THE ROOT CAUSES RELATED WITH THIS DEFECT, IT WAS IDENTIFIED THE FOLLOWING: -AN EVALUATION WAS CARRIED OUT DURING THE SEALING AND PACKAGING PROCESS IN BODOLAY LINE AND IT WAS OBSERVED WHEN THE DRESSING ARE OUT OF THE CENTER OF PACKAGING MATERIAL, GET IN CONTACT WITH SEALING AREA, THE PLATES GET DIRTY, HINDERING THE HEAT TRANSFERENCE OF THE CURRENT PIECES SEALING AND THE FOLLOWING CYCLES CAUSING INCOMPLETE SEALING. -CURRENT VISION SYSTEM SCOPE IT CAN IDENTIFY THE FOLLOWING DEFECTS, LOSS DRESSING, TRAPPED IN THE SEAL, EMPTY BLISTER, DOUBLE DRESSING, CUT DRESSING, RED TAPE. THE OPPORTUNITY IS RELATED TO UPGRADE THE CURRENT VISION SYSTEM TO ENSURE THE CAPTURE OF CHANNEL AND OPEN SEAL DURING MANUFACTURING PRODUCTION. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT WAS APPROVED AND 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

    IT WAS REPORTED BY DISTRIBUTOR THAT THERE WAS DAMAGE TO PACKAGING AND SEAL WAS INCOMPLETE WITH PACKAGE SIDE CUT. THE NOTIFICATION WAS RECEIVED FROM HOSPITAL. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223427 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187957 2K03536 00768455150939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown