BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS C VIOLET 2/0 (3) 25M

    MDR report key: 17697140 · Received September 7, 2023

    Report

    Report Number
    3003639970-2023-00299
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Report Date
    October 23, 2023
    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
    Health Professional
    Yes

    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) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE NOT RECEIVED ANY SAMPLES OR PICTURES. WITHOUT CLOSED AND/OR DEFECTIVE 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: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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

    G4: REPORTED DEVICE MARKETED IN ONLY FOR VETERINARY USE, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. RELATED 510K NUMBER K031216. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOPLUS SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT A NEW CASSETTE WAS OPENED AND, WHEN TRYING TO PULL THE SUTURE THREAD UP, THE THREAD FELL OFF AND THEN BROKE INSIDE THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926307 MONOPLUS C VIOLET 2/0 (3) 25M SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A. F0024272 122435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown