BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6808028 · Received August 21, 2017

    Report

    Report Number
    3004365956-2017-00331
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 14, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED TO ONE (1) SAMPLE RECEIVED OF PRODUCT CODE 833-114 (TEV GN BR 0 TC-43/HR26 2N 36"). THIS PRODUCT CONFIGURATION IS NEEDLE-BULLET BUT AS PART OF THIS CUSTOMER IT WAS ONLY RECEIVED THE SUTURE WITH NEEDLE ATTACHED TO ONE END. THE OTHER END OF THE SUTURE LOOKS STRESS SURFACE AND BULLET IS MISSING. THE DEVICE HISTORY RECORD OF THE FG INVOLVED HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. ALTHOUGH THE SUTURE RETURNED FOR EVALUATION SHOWS TEARING CONDITIONS ON BULLET SECTION, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THAT THIS FAILURE MODE WAS ORIGINATED DURING THE MANUFACTURING PROCESS. ALTHOUGH THE SUTURE RETURNED FOR EVALUATION SHOWS TEARING CONDITIONS ON BULLET SECTION, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THAT THIS FAILURE MODE WAS ORIGINATED DURING THE MANUFACTURING PROCESS. SUTURE AND BULLET RELATED TO THE INVOLVED BATCH SHOWS THAT WERE RECEIVED WITHIN THE SUPPLIER SPECIFICATIONS. THE ROOT CAUSE FOR THIS CONDITION REPORTED COULD NOT BE IDENTIFIED, HOWEVER PERSONNEL INVOLVED ON THE MANUFACTURING OF THIS PRODUCT HAS BEEN NOTIFIED. THE NUEVO LAREDO FACILITY WILL OTHER REMARKS: CONTINUE TRACKING AND TRENDING THIS FAILURE MODE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS NOT MADE SINCE AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS ANY BEING MANUFACTURED AT THE TIME. IF THE DEFECTIVE SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. THE DEVICE HISTORY RECORD OF BATCH NUMBER PROVIDED HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO REJECTION REPORT WAS ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DEVICE HISTORY REVIEW SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO CORRECTIVE ACTIONS CAN BE IMPLEMENTED DUE THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF A PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND TO DETERMINE THE ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED FOR A HYSTERECTOMY CYSTOSCOPY WHEN THE BULLET END OF THE SUTURE CAME OFF INSIDE THE PATIENT AND WAS UNABLE TO BE RETRIEVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE DEVICE WAS USED FOR A HYSTERECTOMY CYSTOSCOPY WHEN THE BULLET END OF THE SUTURE CAME OFF INSIDE THE PATIENT AND WAS UNABLE TO BE RETRIEVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587581 TEV GN BR 0 TC-43/HR26 2N 36" SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL 74L1600473

    Patients

    Seq Age Sex Outcome Treatment
    1