BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE

    MDR report key: 9717660 · Received February 17, 2020

    Report

    Report Number
    3003639970-2020-00099
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Report Date
    February 24, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    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

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED AN OPEN AND USED CASSETTE WITH THE THREAD BROKEN INSIDE THE CASSETTE AND IT IS NOT USEFUL. THEREFORE, IN THESE CONDITIONS WE CAN NOT TESTED THE THREAD OF THE CASSETTE RECEIVED. THREAD WAS PROBABLY TANGLED IN THE REEL AND WHEN PULLED OUT FROM CASSETTE THE THREAD BROKE BECAUSE THE EXTRACTION WAS TOO HARD. 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: TAKING INTO ACCOUNT THAT SAMPLE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS DUE TO THE THREAD IS BROKEN INSIDE THE CASSETTE AND IT IS NOT USEFUL, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED, 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

    PMA/510K: 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. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD IS BRITTLE AND KEEPS SNAPPING. THE REPORTER INDICATED A PRACTICE RETURNED A CASSETTE OF 3M CATGUT IN WHICH THE THREAD SEEMED TO HAVE GONE VERY BRITTLE AND KEPT FRAYING AND BREAKING. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181447 MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE CATGUT CHROM CASSETTES GAL B.BRAUN SURGICAL SA 41167201 618303

    Patients

    Seq Age Sex Outcome Treatment
    1