BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 3/0 (2) 70CM HR22 (M)RCP

    MDR report key: 12251437 · Received July 30, 2021

    Report

    Report Number
    3003639970-2021-00328
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 8, 2021
    Report Date
    July 30, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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., K031216. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE 1 OPEN SAMPLE CONTAINING ONLY THE NEEDLE, THE THREAD IS MISSING. WITHOUT CLOSED SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. 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. 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 WHEN OPENING THE PACKAGE AND GRASPED THE SUTURE, THE NEEDLE CAME OFF. THERE IS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151859 MONOPLUS VIOLET 3/0 (2) 70CM HR22 (M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A. C2024135 120232

    Patients

    Seq Age Sex Outcome Treatment
    1