BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKNATAL BL MF 0 TC-43 2N 48"

    MDR report key: 3190580 · Received June 21, 2013

    Report

    Report Number
    3004365956-2013-00203
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY REPORT (DHR) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND THAT COULD POTENTIALLY RELATE TO THIS COMPLAINT. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO REJECTION REPORT WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. TENSILE STRENGTH TEST CARD WERE REVIEWED AND THERE IS NO INDICATION OF FUNCTIONAL FAILURES. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME DUE THE LACK OF DEFECTIVE PRODUCT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE POLYPROPYLENE 48IN SIZE 0 (2 TAPERCUTS) SEPARATED FROM THE SUTURE. THE NEEDLE HAD DETACHED FROM THE SUTURE. CONTACT DID NOT HAVE ANY OTHER DETAILS AND WAS NOT ABLE TO CONFIRM IF THE EVENT OCCURRED INSIDE OR OUTSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282977 DEKNATAL BL MF 0 TC-43 2N 48" SUTURE GAT TELEFLEX MEDICAL 02F1003349

    Patients

    Seq Age Sex Outcome Treatment
    1