BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFB BK CO-BR 2 HC 1N 36" TORNIER

    MDR report key: 2854396 · Received November 29, 2012

    Report

    Report Number
    3004365956-2012-00329
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 8, 2012
    Manufacturer
    TELEFLEX
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW SHOWED NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD BE POTENTIALLY RELATE TO THIS COMPLAINT. NO REJECTION REPORTS WERE ORIGINATED FOR THIS LOT#. DHR SHOWS THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. TENSILE STRENGTH TEST CARDS WERE REVIEWED AND THERE IS NO INDICATION OF FUNCTIONAL FAILURES. PREVIOUS AND SUBSEQUENT BATCHES FROM 2012 AND 2011 WERE REVIEWED, AND THERE IS NO INDICATION OF FUNCTIONAL FAILURES IN TENSILE STRENGTH. DATA BASE OF REJECTION REPORTS WAS REVIEWED FOR THIS CODE FROM 2010 TO 2011, AND THERE IS NO INDICATION OF FUNCTIONAL FAILURES IN TENSILE STRENGTH. NO INVENTORY OF THIS LOT# IS AVAILABLE AT THE DISTRIBUTION CENTER FOR FURTHER INVESTIGATION. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. NO CORRECTIVE ACTIONS TAKEN.

    Description of Event or Problem · 1

    COMPLAINT REPORTED AS: NEEDLE CAME OFF OF SUTURE DURING USE AND WAS RETRIEVED AT THE TIME IF FELL OFF. PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FFB BK CO-BR 2 HC 1N 36" TORNIER SUTURE GAT TELEFLEX 02E1103116

    Patients

    Seq Age Sex Outcome Treatment
    1