BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 5 KAC-25 1N 24" NICELOOP

    MDR report key: 20968981 · Received December 18, 2024

    Report

    Report Number
    3004365956-2024-00092
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    September 25, 2024
    Report Date
    November 27, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION AND PICTURE PROVIDED; TO PERFORM A PROPER EVALUATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED & INSPECTED ACCORDING TO OUR SPECIFICATIONS. THE DHR RECORDS SHOWS THAT THE TENSION TESTS MET THE SPECIFICATIONS ABOVE THE INDIVIDUAL MINIMUM EXPECTED OF 2 LBS, THE AVERAGE OF THE RESULTS OBTAINED WAS 14.72 LBS. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE. IF THE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "TWO NICE LOOPS BROKE IN THE SAME CASE. FROM THE INFORMATION PROVIDED UPON THE REPORTER'S INITIAL COMPLAINT. IT HAPPENED DURING SURGERY, THERE WAS NO IMPACT TO PATIENT, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "TWO NICE LOOPS BROKE IN THE SAME CASE. FROM THE INFORMATION PROVIDED UPON THE REPORTER'S INITIAL COMPLAINT. IT HAPPENED DURING SURGERY, THERE WAS NO IMPACT TO PATIENT, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949391 TEV GN BR 5 KAC-25 1N 24" NICELOOP SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown