BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 0 (3.5) 75CM HR37S (M)

    MDR report key: 3880710 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00402
    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

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 21 UNOPENED AND 1 OPEN RACEPACK. THIS IS THE SECOND COMPLAINT OF THIS CODE/BATCH (FIRST ONE WAS JUSTIFIED). THERE ARE NO UNITS IN OEM STOCK. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE OEM. NEEDLE ATTACHMENT RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT FULFILLED OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: OEM HAS OPENED A CORRECTIVE ACTION IN ORDER TO AVOID THIS KIND OF INCIDENT IN THE FUTURE.

    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
    313866 PREMILENE 0 (3.5) 75CM HR37S (M) CARDIAC SUTURE GAW B. BRAUN SURGICAL S.A. C2090152 112041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other