BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43/HR 26 2N

    MDR report key: 15508432 · Received September 29, 2022

    Report

    Report Number
    3004365956-2022-00072
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    June 22, 2022
    Report Date
    September 9, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    UDI-DI
    14026704603890
    PMA / PMN Number
    K930738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL, DIMENSIONAL, OR FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74C1800882 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE THE SAMPLE INVOLVED IN THE CUSTOMER COMPLAINT WAS NOT SENT FOR ANALYSIS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THIS TIME THIS PRODUCT CODE ARE NO LONGER MANUFACTURING AND HAS BEEN DISCONTINUED. IF THE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DART DETACHED. THERE WERE NO CLINICAL SIGNS OR SYMPTOMS OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585120 DEK BL MF 0 TC-43/HR 26 2N SUTURE, NONABSORBABLE, SYNTHE GAW TELEFLEX MEDICAL IPN000861 74C1800882 14026704603890

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown