BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOCRIN 5/0 (1) 60CM DS16

    MDR report key: 10688248 · Received October 16, 2020

    Report

    Report Number
    3003639970-2020-00354
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 2, 2020
    Report Date
    October 16, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. K990090. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED ONE OPEN AND UNUSED SAMPLE FOR ANALYSIS. THE NEEDLE IS DETACHED FROM THE THREAD AND THE THREAD IS STILL WOUND ON THE PACK. THE THREAD OF THE SAMPLE RECEIVED IS BROKEN AT THE END OF ATTACHMENT WITH THE NEEDLE. THE NEEDLE WAS PROBABLY ATTACHED WITH TOO MUCH STRENGTH GENERATING A WEAK POINT AND WHEN TRYING TO EXTRACT FROM THE PACK, THE THREAD BROKE AT THE ATTACHMENT POINT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLE RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. WE APOLOGIZE 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. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX OF PRODUCT AS COMPENSATION. 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 THAT THERE WAS AN ISSUE WITH FLEXOCRIN SUTURE. THE CLIENT REPORTED THAT DETACHMENT OF THE NEEDLE FROM THE THREAD OCCURRED FOUR TIMES. ADDITIONAL DATA HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157089 FLEXOCRIN 5/0 (1) 60CM DS16 OTHER SUTURE GAR B. BRAUN SURGICAL, S.A. C0862274 618085

    Patients

    Seq Age Sex Outcome Treatment
    1