BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 5/0 (1)45CM DSMP11(M).RCP

    MDR report key: 12795714 · Received November 11, 2021

    Report

    Report Number
    3003639970-2021-00537
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 12, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: CORRECTED, PMA/510K NUMBER: K011375.

    Additional Manufacturer Narrative · 0

    K011375; REPORTED DEVICE NOT MARKETED IN THE US, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE US. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 1,656 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD THAT SEEMS UNUSED. THE THREAD IS NOT WOUND ON THE PACK. HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS 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 ANALYSE 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. 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 · 0

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT REPORTED THAT WHEN THEY OPENED THE PACKAGE, THE THREAD WAS DETACHED. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693474 MONOSYN UNDYED 5/0 (1)45CM DSMP11(M).RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2023643 121145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown