BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 3/0 (2) 70CM DS19 (M)

    MDR report key: 9379689 · Received November 26, 2019

    Report

    Report Number
    3003639970-2019-00860
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 4, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLE RECEIVED: 1 OPEN POUCH, NEEDLE DETACHED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. (B)(4). WE HAVE RECEIVED ONE OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD AND THE THREAD IS STILL 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 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/PREVENTIVE ACTIONS ARE NEEDED.

    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. K011375. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED NEEDLE DETACHMENT. THE REPORTER INDICATED THAT THE NEEDLE IS DETACHED FROM THE SUTURE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173662 MONOSYN VIOLET 3/0 (2) 70CM DS19 (M) SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C0022205 116081

    Patients

    Seq Age Sex Outcome Treatment
    1