BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 0 (3.5) 75CM HRT37 (M)

    MDR report key: 4954217 · Received July 22, 2015

    Report

    Report Number
    2916714-2015-00622
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAQ
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 107 UNOPENED AND 4 OPENED RACEPACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. RECEIVED 107 CLOSED SAMPLES AND 4 OPEN SAMPLES WITH THE NEEDLE DETACHED FROM THE THREAD. THERE ARE NO NEEDLES INSIDE THE OPEN SAMPLES AND THE THREAD IS STILL WOUND ON THE PACK. NEEDLE ATTACHMENT TESTING OF THE CLOSED SAMPLES RECEIVED WAS COMPLETED AND THE RESULTS OF ONE OF THE SAMPLES DID NOT FULFILL THE REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT JUSTIFIED. CORRECTIVE/PREVENTIVE ACTIONS: THERE IS A CORRECTIVE ACTION INITIATED IN ORDER TO AVOID THIS KIND OF INCIDENT IN THE FUTURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINTS: (B)(6). THE NEEDLE IS DETACHED FROM THE THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474873 PREMILENE 0 (3.5) 75CM HRT37 (M) GAQ B. BRAUN SURGICAL S.A. C2090453 114054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other