BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE, TC-43 2N 48"

    MDR report key: 1915420 · Received November 5, 2010

    Report

    Report Number
    3004365956-2010-00328
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 19, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MFJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: OTHER - DEVICE HISTORY RECORD (DHR) REVIEW. RESULTS: DHR REVIEW FOR THE REPORTED LOT NUMBER SHOWED NO ISSUES OR DISCREPANCIES WHICH COULD POTENTIALLY RELATE TO THE COMPLAINT REPORTED. TESTS CARDS WERE REVIEWED FROM MANUFACTURING AND QUALITY, FINDING THAT ON THAT ATTACHMENT STRENGTH TEST THE INDIVIDUAL MINIMUM VALVE ON THE MANUFACTURING TEST CARD WAS 7.0LBS AND ON THE QUALITY TEST CARD WAS 7.8LBS IN COMPARISON WITH THE REQUIREMENTS ON THE INDIVIDUAL MINIMUM VALUE OF 5.8LBS. CONCLUSIONS: DEVICE NOT RETURNED - NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN. CUSTOMER COMPLAINT CAN BE CONFIRMED DUE TO LACK OF SAMPLE FOR INVESTIGATION. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS TIME.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BULLET RELEASED OFF THE SUTURE MATERIAL. THE BULLET REMAINED IN THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE, TC-43 2N 48" SUTURE MFJ TELEFLEX MEDICAL NA 02H0901129

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK