BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 5/0 (1) 45CM DS16 (M).RCP

    MDR report key: 11549687 · Received March 23, 2021

    Report

    Report Number
    3003639970-2021-00069
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    April 8, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    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 · 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS AND RESULTS: (B)(4). WE HAVE RECEIVED AN OPEN AND UNUSED SAMPLE WITHOUT NEEDLE. THE THREAD IS NOT WOUND ON THE PACK. WITHOUT CLOSED SAMPLES A PROPER ANALYSIS CANNOT BE DONE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL 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 ANALYSE IT. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT REPORTED THAT THE NEEDLE DETACHES FROM THE THREAD. VETERINARY USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454092 MONOSYN VIOLET 5/0 (1) 45CM DS16 (M).RCP SYNTHETIC ABSORBABLE MONOFILAR GAM B. BRAUN SURGICAL, S.A. C2022419 120045

    Patients

    Seq Age Sex Outcome Treatment
    1