BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43 2N 48"

    MDR report key: 6572443 · Received May 17, 2017

    Report

    Report Number
    3004365956-2017-00188
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 26, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. INCOMING INSPECTION RECORDS OF THE SUTURE P/N 123074 BATCH NUMBER 07F1600136 FROM SUPPLIER DOES NOT SHOW ANY QUALITY ISSUES REGISTERED DURING INSPECTION. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED AND NO CORRECTIVE ACTIONS CAN BE IMPLEMENTED SINCE THE PRODUCT SAMPLE IS NEEDED TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. THE ROOT CAUSE IS UNKNOWN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE CAPIO SUTURE BROKE AND THE NEEDLE DETACHED IN THE MIDDLE WITH THE FIRST THROW. WE WERE THEN ABLE TO EASILY BREAK THE SUTURE PIECES WITH MINIMAL TRACTION. THE PATIENT'S CONDITION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352690 DEK BL MF 0 TC-43 2N 48" GAW TELEFLEX MEDICAL 74H1600229

    Patients

    Seq Age Sex Outcome Treatment
    1