BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 3/0 (2) 70CM HR26 (M) RCP

    MDR report key: 18100341 · Received November 9, 2023

    Report

    Report Number
    3003639970-2023-00375
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 24, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER IS MODIFIED; 122444 INSTEAD OF 123163 AS REPORTED IN THE INITIAL MEDWATCH. ANALYSIS AND RESULTS: THE SAMPLE RECEIVED HAD A DIFFERENT BATCH AS THE INFORMED. THE INFORMED AND SECOND PACK BATCH IS 123163 NEVERTHELESS, THE PRODUCT INSIDE THE POUCH HAS THE BATCH 122444. WE HAVE CHANGED THE BATCH TO 122444 AS IS THE ONE FROM THE SAMPLE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 5,724 UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD AND THE THREAD IS STILL WOUND ON THE PACK. 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.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT REPORTED THAT UPON OPENING THE PACKAGE, THE NEEDLE AND THREAD WERE ALREADY SEPARATED. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866591 MONOSYN VIOLET 3/0 (2) 70CM HR26 (M) RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2022025 122444

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown