BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROMIC 2 (6) 50M

    MDR report key: 11377373 · Received February 25, 2021

    Report

    Report Number
    3003639970-2021-00044
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Report Date
    May 21, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAL
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE-BATCH REGARDING THREAD TANGLED AND CLOSED AS CONFIRMED AFTER ANALYSIS. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 239 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. 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. WE APOLOGISE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED, AND THANK YOU FOR YOUR COLLABORATION. 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. YOU WILL RECEIVE A CREDIT NOTE FOR ONE CASSETTE 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.

    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: K991223. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH CATGUT SUTURE. THE CLIENT REPORTED THAT THE THREAD BROKE DURING SURGERY (VETERINARY USE). NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279532 CATGUT CHROMIC 2 (6) 50M OTHER SUTURE GAL B. BRAUN SURGICAL, S.A. F1154087 619463

    Patients

    Seq Age Sex Outcome Treatment
    1