BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS C VIOLET 2/0 (3) 25M

    MDR report key: 10513777 · Received September 10, 2020

    Report

    Report Number
    3003639970-2020-00323
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    September 18, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4). THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN AND USED CASSETTE. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE THREAD IN THE CASSETTE RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 3.76 KGF IN AVERAGE AND 3.47 KGF IN MINIMUM (EP REQUIREMENTS: 2.73 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM). 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: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. WE REGRET ANY INCONVENIENCE 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. (K031216). IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH MONOPLUS VIOLET SUTURE. THE CLIENT REPORTED THAT THE THREAD BROKE DURING SURGERY. VETERINARY CASE. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981589 MONOPLUS C VIOLET 2/0 (3) 25M SYNTHETIC ABSORBABLE MONOFILAR NEW B. BRAUN SURGICAL, S.A. F0024272 119295

    Patients

    Seq Age Sex Outcome Treatment
    1