BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 0 TC-43 2N 48"

    MDR report key: 7125483 · Received December 18, 2017

    Report

    Report Number
    3004365956-2017-00425
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 27, 2017
    Report Date
    December 4, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K021019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. VISUAL INSPECTION WAS PERFORMED TO ONE (1) SAMPLE RECEIVED OF PRODUCT CODE 833-113 (TEV GN BR 0 TC-43 2N 48") SAMPLE WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING, PRODUCT CODE CONFIGURATION CONSIST IN BULLET-BULLET AND IT WAS NOT RECEIVED COMPLETE ACCORDING THIS CONFIGURATION RECEIVING ONLY 1 BULLET ATTACHED TO SUTURE. SUTURE WAS RECEIVED IN PARTS WHERE CAN BE OBSERVED TORN CONDITION IN ENDS OF SUTURE, THE BULLET ATTACHMENT SECTION PRESENT AN ACCEPTABLE CONDITION. A DIMENSIONAL INSPECTION OF THE SUTURE INVOLVED WAS PERFORMED OBTAINING ACCEPTABLE RESULTS (CONSIDERING ALL PIECES OF SUTURE RECEIVED) ACCORDING TO QA-SUT-001/F2. FUNCTIONAL INSPECTION WAS PERFORMED TO BULLET ATTACHED OBTAINING ACCEPTABLE RESULTS ACCORDING TO SPECIFIED IN WI-002567/F1. A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. ALTHOUGH THE SUTURE WAS RECEIVED IN PIECES, THERE IS NO S UFFICIENT EVIDENCE TO ASSURE THAT THIS FAILURE MODE WAS ORIGINATED OTHER REMARKS: DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BEING MANUFACTURED AT THE TIME. IF THE DEFECTIVE SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTIONS CAN BE IMPLEMENTED DUE THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE SUTURE BROKE OFF IN THE PATIENT WHEN THEY WERE DEPLOYING IT. WHEN THEY PULLED THE CAPIO OUT, THEY REALIZED THAT THE BULLET WAS NOT ON THE END OF THE SUTURE. THEY TRIED TO RETRIEVE WHAT THEY COULD BUT THEY COULD NOT SEE IT. THEY BROUGHT AN X-RAY IN AND REALIZED THAT IS WAS STILL IN THE PATIENT. THEY JUST LEFT IT ALONE AND FINISHED THE PROCEDURE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE SUTURE BROKE OFF IN THE PATIENT WHEN THEY WERE DEPLOYING IT. WHEN THEY PULLED THE CAPIO OUT, THEY REALIZED THAT THE BULLET WAS NOT ON THE END OF THE SUTURE. THEY TRIED TO RETRIEVE WHAT THEY COULD BUT THEY COULD NOT SEE IT. THEY BROUGHT AN X-RAY IN AND REALIZED THAT IS WAS STILL IN THE PATIENT. THEY JUST LEFT IT ALONE AND FINISHED THE PROCEDURE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903973 TEV GN BR 0 TC-43 2N 48" SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1