BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 3/0 (3) 100M

    MDR report key: 10095153 · Received May 28, 2020

    Report

    Report Number
    3003639970-2020-00213
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Report Date
    June 8, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAL
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED ONE OPEN AND USED CASSETTE FOR ANALYSIS. THREAD ON SAMPLE RECEIVED IS BROKEN INSIDE THE CASSETTE AND IT IS NOT USEFUL. THREAD WAS PROBABLY TANGLED IN THE REEL AND WHEN PULLED OUT FROM CASSETTE THE THREAD BROKE BECAUSE THE EXTRACTION WAS TOO HARD. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE CASSETTE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE SAMPLE RECEIVED. ACTIONS ON DISTRIBUTED PRODUCT 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. K991223. IF FURTHER DATA BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH CATGUT SUTURE. THE THREAD CRACKED WITHIN THE CASSETTE. VETERINARY USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562938 CATGUT PLAIN 3/0 (3) 100M CATGUT PLAIN CASSETTES GAL B. BRAUN SURGICAL, S.A. F1144049 619393

    Patients

    Seq Age Sex Outcome Treatment
    1