BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFB BL CO-BR 2 HC-5 1N 38" STRYKER

    MDR report key: 10546710 · Received September 17, 2020

    Report

    Report Number
    3004365956-2020-00195
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    May 29, 2020
    Report Date
    September 4, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K063778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 3910-900-020 / BATCH 74B1901565 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. A CORRECTIVE ACTION CAN NOT BE IMPLEMENTED AT THE TIME SINCE THE SAMPLE INVOLVED IN THE CUSTOMER COMPLAINT WAS NOT SENT FOR ANALYSIS. CUSTOMER COMPLAINT CAN NOT BE CONFIRMED SINCE THE PRODUCT SAMPLE INVOLVED IN THE COMPLAINT NOTIFICATION WAS NOT PROVIDED TO A PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    ISSUE REPORTED: AT THE TIME OF PASSING THE SUTURE, THE NEEDLE SEPARATED FROM THE SUTURE WITHOUT PERFORMING ANY KIND OF FORCE. THE EVENT WAS NOT A DISASSEMBLING IT WAS A SEPARATION BETWEEN THE NEEDLE AND THE SUTURE. NEITHER THE NEEDLE NOR THE SUTURE PRESENTED RUPTURES. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    QN#: (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

    ISSUE REPORTED: AT THE TIME OF PASSING THE SUTURE, THE NEEDLE SEPARATED FROM THE SUTURE WITHOUT PERFORMING ANY KIND OF FORCE. THE EVENT WAS NOT A DISASSEMBLING IT WAS A SEPARATION BETWEEN THE NEEDLE AND THE SUTURE. NEITHER THE NEEDLE NOR THE SUTURE PRESENTED RUPTURES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013221 FFB BL CO-BR 2 HC-5 1N 38" STRYKER SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL 74B1901565

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.