BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 2/0 (3) 75CM H37S (M)

    MDR report key: 3880679 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00401
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 35 UNOPENED RACEPACKS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. THERE ARE NO UNITS IN OEM STOCK. TESTED ARE NO UNITS IN OEM STOCK. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. REMARKS: THE COMPLAINT IS JUSTIFIED FOR ISOLATED DETACHED NEEDLES, BUT THE CONCLUSION IS NOT CORRESPONDING ACCORDING TO THE RESULTS OF THE SAMPLES TESTED. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). CORRECTIVE/PREVENTATIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IN HERNIOPLASTIA SURGERY, FOUR CASES OF NEEDLE DETACHMENT, TWO WITH PREMILENE 0 AND 2 WITH PREMILENE 2/0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314176 PREMILENE 2/0 (3) 75CM H37S (M) CARDIAC SUTURE GAW GAW B. BRAUN SURGICAL S.A. C2090151 113032

    Patients

    Seq Age Sex Outcome Treatment
    1