BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEV GN BR 0 TC-43 48" 2N

    MDR report key: 2833514 · Received October 30, 2012

    Report

    Report Number
    3004365956-2012-00309
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 18, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR INVESTIGATION. NO LOT # WAS PROVIDED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF PRODUCT SAMPLE AND LOT # TO PERFORM A PROPER INVESTIGATION AND DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE SURGEON LOADED THE CAPIO DEVICE WITH THE SUTURE, AND WHEN HE WENT TO THROW THE SUTURE NEEDLE WOULD DISLODGE, AFTER SEVERAL ATTEMPTS, HE DECIDED TO USE ANOTHER CAPIO DEVICE AND HE COMPLETED THE PROCEDURE SUCCESSFULLY. NO REPORTED PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEV GN BR 0 TC-43 48" 2N SUTURE GAW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1