BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET (4) 150CM HRT48 LOOP (M

    MDR report key: 4356034 · Received December 9, 2014

    Report

    Report Number
    2916714-2014-00926
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Report Date
    December 4, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED: (B)(6) 2014. COMPLAINT DESCRIPTION: CORRECTIVE GASTRECTOMY SURGERY PERFORMED, ON PATIENT THAT EXPERIENCED A EVISCERATION; DUE TO BROKEN THREADS. INITIAL SURGEON USED MONOMAX 1 HRT-48 FOR THE CLOSURE AND COMPLETION OF THE GASTRECTOMY. IT WAS NOTED AND OBSERVED THAT THE INITIALLY USED THREADS WERE BROKEN; ALTHOUGH THE END KNOTS WERE STILL ATTACHED TO THE WALL. POLYGLACTIN 1 SUTURES WERE USED FOR THE CORRECTIVE GASTRECTOMY SURGERY. SAMPLES RECEIVED: 1 OPEN POUCH (CANNOT BE USED FOR TESTING). OEM REQUIRES CLOSED SAMPLES FOR EVALUATIONS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN THE OEM STOCK. OEM REQUIRES A CLOSED SAMPLE FOR TESTING AND EVALUATION. WITH NO CLOSED SAMPLES, OEM CANNOT CARRY OUT AN ANALYSIS IN ORDER TO MAKE AN INFORMED DECISION. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS CONFORM TO OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON THE PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTATIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CORRECTIVE GASTRECTOMY SURGERY PERFORMED, ON PATIENT THAT EXPERIENCED A EVISCERATION; DUE TO BROKEN THREADS. INITIAL SURGEON USED MONOMAX 1 HRT-48 FOR THE CLOSURE AND COMPLETION OF GASTRECTOMY. IT WAS NOTED AND OBSERVED THAT THE INITIALLY USED THREADS WERE BROKEN; ALTHOUGH THE END KNOTS WERE STILL ATTACHED TO THE WALL. POLYGLACTIN 1 SUTURES WERE USED FOR THE CORRECTIVE GASTRECTOMY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797002 MONOMAX VIOLET (4) 150CM HRT48 LOOP (M POLYHYDROXYBUTYRATE SUTURE NWJ B. BRAUN SURGICAL S.A. B0041222 113285

    Patients

    Seq Age Sex Outcome Treatment
    1 Other