BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 4/0(1,5)70CM HR26 (M)RCP

    MDR report key: 12335206 · Received August 18, 2021

    Report

    Report Number
    3003639970-2021-00336
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 19, 2021
    Report Date
    October 8, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE TWO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH REGARDING THE SAME ISSUE (BOTH CLOSED AS CONFIRMED AFTER ANALYSIS). WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD, AND THE THREAD IS STILL WOUND ON THE PACK. THE THREAD IS ESCAPED FROM THE NEEDLE. 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. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 1.08 KGF IN AVERAGE AND 0.49 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS. HOWEVER, CONSIDERING THE DEFECTIVE SAMPLE RECEIVED AND THE PREVIOUS CONFIRMED COMPLAINTS, WE CONSIDER THIS CASE AS CONFIRMED AS WELL. FINAL CONCLUSION: WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. WE APOLOGISE FOR ANY INCONVENIENCE THAT 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.

    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. UNDER PMA/510(K) NUMBER: K031216. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH MONOPLUS SUTURE. THE CLIENT REPORTED AN OUT OF THE BOX FAILURE: NEEDLE IS NOT CONNECTED TO THE THREAD. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237421 MONOPLUS VIOLET 4/0(1,5)70CM HR26 (M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A. C2024024 120491

    Patients

    Seq Age Sex Outcome Treatment
    1