BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 17754497 · Received September 15, 2023

    Report

    Report Number
    9618003-2023-03984
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Report Date
    August 21, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    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 IMDRF CAUSE INVESTIGATION CODE. H10: INVESTIGATION SUMMARY RETURNED SAMPLE EVALUATION: PHOTOS ASSOCIATED WITH THIS CASE WERE RECEIVED FOR EVALUATION. PHOTOGRAPHS WERE RECEIVED AND ACCESSED AND THERE IS NO CHANGE TO THE EXISTING INVESTIGATION WITH THE CODE. 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

    E1: COMPLAINANT STATE: (B)(6). COMPLAINANT COUNTRY: JAPAN. NAME OF AFFILIATION: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. RETURNED SAMPLE EVALUATION: NO PHOTOS ASSOCIATED WITH THIS CASE WERE RECEIVED FOR EVALUATION. BATCH RECORD REVIEW: THE LOT 2J00442 WAS MANUFACTURED ON 13 SEP 2022 BODOLAY MANUFACTURING LINE, WITH A TOTAL OF (B)(4) UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 17 AUG 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 1000854 AND MANUFACTURING ORDER 1643631. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. INVESTIGATION CONCLUSION: 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 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY A RETAILER THAT PRIMARY PACKAGE WAS OPENED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039699 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187660 2J00442

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown