BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 0 TC-43/HR26 2N 36"

    MDR report key: 12213577 · Received July 22, 2021

    Report

    Report Number
    3004365956-2021-00248
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    July 15, 2021
    Report Date
    July 20, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    UDI-DI
    14026704603876
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-114 / BATCH 74C1902282 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. REFER TO ATTACH. A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE THE SAMPLE INVOLVED IN THE CUSTOMER COMPLAINT WAS NOT SENT FOR ANALYSIS. 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 THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY IS NOT BEING MANUFACTURED AT THE TIME. IF THE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 0

    DURING SACROSPINOUS FIXATION AFTER TRIGGERING THE CAPIO AND WHEN THE DOCTOR DRAGGED THE SUTURE THE SUTURE TORE SUDDENLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    DURING SACROSPINOUS FIXATION AFTER TRIGGERING THE CAPIO AND WHEN THE DOCTOR DRAGGED THE SUTURE THE SUTURE TORE SUDDENLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109099 TEV GN BR 0 TC-43/HR26 2N 36" SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL IPN000859 74C1902282 14026704603876

    Patients

    Seq Age Sex Outcome Treatment
    1