BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 5/0 (1) 70CM DS12 (M).RCP

    MDR report key: 9078881 · Received September 17, 2019

    Report

    Report Number
    3003639970-2019-00644
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Report Date
    September 20, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION - ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED AN OPEN AND UNUSED SAMPLE WITHOUT NEEDLE ATTACHED TO THREAD. THREAD IS STILL WOUND ON THE PACK. HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO MAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORD, THERE ARE NO INCIDENCES RELATED TO THIS ISSUE AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT.

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K011375. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MONOSYN. UPON OPENING THE PACKETS, IT WAS NOTED THAT THE NEEDLES HAD COME OFF THE SUTURES. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870135 MONOSYN UNDYED 5/0 (1) 70CM DS12 (M).RCP SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C2023413 118496

    Patients

    Seq Age Sex Outcome Treatment
    1