BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 5/0 (1) 45CM DS16 (M)

    MDR report key: 4203746 · Received July 22, 2014

    Report

    Report Number
    2916714-2014-00506
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    B.BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: STOCK REVIEW: THERE ARE NOT UNITS IN OEM STOCK. IMPORTED/ MANUFACTURED QUANTITY: (B)(4) UNITS WERE MANUFACTURED OF THIS CODE/BATCH. DISTRIBUTED QUANTITY: ALL THE UNITS WERE COMMERCIALIZED AT 17 NATIONAL CUSTOMERS. CASEWORK: THERE ARE NOT ANY SIMILAR REPORTS ABOUT THIS CODE/BATCH. BATCH RECORD REVIEW: REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. BATCH RELEASE RESULTS: THE RESULTS OBTAIN IN RELATION WITH THE NEEDLE DETACHMENT TO RELEASE THIS BATCH FULFILLED ALL REQUIREMENTS. RECEIVED SAMPLES: WE RECEIVED 2 UNOPENED POUCHES. ALL PACKS RECEIVED TESTED FOR NEEDLE DETACHMENT TEST AND THE TWO RECEIVED SAMPLES FULFILL OEM REQUIREMENTS. CORRECTIVE ACTION: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). UPON REMOVING SUTURE FROM PACKAGING AND PLACING ON NEEDLE HOLDER, THE NEEDLE DETACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429401 PREMILENE 5/0 (1) 45CM DS16 (M) NON-CARDIOVASCULAR GAW B.BRAUN SURGICAL S.A. C0095714 513283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other