BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 2/0 (3) 75CM GS50 (M) .RCP

    MDR report key: 3960950 · Received May 23, 2014

    Report

    Report Number
    2916714-2014-00379
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K012201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 UNOPENED RACEPACKS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE 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 ANORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTION ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SUTURES IS STILL IN SEALED FOILED BUT NEEDLE IS SEPARATED FROM THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309322 PREMILENE 2/0 (3) 75CM GS50 (M) .RCP CARDIA SUTURE GAW B. BRAUN SURGICAL S.A. C2090266 113453

    Patients

    Seq Age Sex Outcome Treatment
    1