BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEELEX STE SET 7 (9) 4X45CM HRS48 LP

    MDR report key: 7112839 · Received December 13, 2017

    Report

    Report Number
    3003639970-2017-00614
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 23, 2017
    Report Date
    January 10, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAQ
    PMA / PMN Number
    K023411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS REFERENCE-BATCH. WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS CODE-BATCH, THERE ARE NO UNITS IN STOCK. WE HAVE RECEIVED ONE BOX LABELED WITH THE CODE G0617795 (STEELEX STE SET 7 (9) 4X45CM HRS48 LP) AND BATCH 617193, BUT CONTAINS (B)(4) UNITS OF THE CODE G0617733 (STEELEX STE SET 5 (7) 4X45CM HRS48 LP) AND BATCH 617194. PRODUCTS TRACEABILITY HAS BEEN CHECKED AND IT HAS BEEN DETERMINED THAT THIS MIX-UP TOOK PLACE AT THE MOMENT OF PREPARING THE SHIPMENT IN THE B. BRAUN SURGICAL ((B)(4)) WAREHOUSE TO B. BRAUN MEDICAL (B)(4). THE OPERATOR TOOK BY MISTAKE STEELEX STERNUM SET 5 (CODE G0617733) AND WAS LABELED AS STEELEX STERNUM SET 7 (CODE G0617795). ADDITIONAL CHECKING WAS NOT CORRECTLY PERFORMED AND THEREFORE IT WAS NOT DETECTED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE. MOREOVER, A NEW DOUBLE CHECK WILL BE IMPLEMENTED IN ORDER TO AVOID THAT THIS ISSUE HAPPENS AGAIN.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INCIDENT: I HAVE ONE ACCIDENT IN BIG HOSPITAL VULSK HEART SURGERY OR WITH STERNUM SET SUTURES 7 G0617795. THEY USES OUR STERNUM SET AND GOT FEW BOXES AND IN ONE BOX INSIDE ARE NOT 7 4X45CM OR 5 4X45CM G0617733. I THINK THAT'S MISTAKE FROM FACTORY. I TOOK THIS REJECT SUTURES AND MUST TO GAVE THEM NEW BOX OF STERNUM SET. AND THIS "MISTAKE" I HAVE NOW IN MY OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894079 STEELEX STE SET 7 (9) 4X45CM HRS48 LP SUTURES GAQ B.BRAUN SURGICAL SA G0617795 617193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other