BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 4/0 (1.5) 70CM HR17 (M)

    MDR report key: 9226958 · Received October 23, 2019

    Report

    Report Number
    3003639970-2019-00743
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Report Date
    October 23, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. K031216. INVESTIGATION: SAMPLES RECEIVED: ONE OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 2,808 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN AND UNUSED SAMPLE WITH ONLY THE SECOND PACK OPENED. THE FIRST PACK (ALUMINUM POUCH) ON THE SAMPLE RECEIVED IS NOT GLUED/SEALED TO THE PEEL FOIL. WE WOULD NEED CLOSED AND/OR DEFECTIVE SAMPLES SHOWING THE DEFECT TO ASSES PROPERLY THE CUSTOMER COMPLAINT. FINAL CONCLUSION: IN SPITE OF RECEIVING AN OPEN SAMPLE, WITHOUT CLOSED AND OR DEFECTIVE SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED AND/OR DEFECTIVE SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTATIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BAD SEALING OF THE PACKAGE. THE REPORTER INDICATED "IT IS NOT POSSIBLE TO REMOVE THE PRODUCTS (SUTURE PACKAGE ) FROM THE PRIMARY PACKAGE DUE TO AN ADDITIONAL WELDING (SOME KIND OF "HOT STAMPING"), WHICH SEALS THE PRODUCTS." NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021184 MONOPLUS VIOLET 4/0 (1.5) 70CM HR17 (M) SYNTHETIC ABSORBABLE MONOFILAR NEW B.BRAUN SURGICAL SA C0024014 119074V004

    Patients

    Seq Age Sex Outcome Treatment
    1