BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 5 (9) 25M

    MDR report key: 9253974 · Received October 29, 2019

    Report

    Report Number
    3003639970-2019-00741
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Report Date
    December 5, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 1 OPEN CASSETTE. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE-BATCH REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B.BRAUN SURGICAL REQUIREMENTS. WE HAVE RECEIVED 1 OPEN CASSETTE FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFIL THE REQUIREMENT OF THE B. BRAUN SURGICAL (BBS): 16.49 KGF IN AVERAGE (BBS REQUIREMENT: >/_9.00 KGF IN AVERAGE). THERE ARE NO EP/USP LIMITS FOR THIS SIZE. THE CASSETTE RECEIVED FULFILS THE FINISHED PRODUCT SPECIFICATIONS AND RAW MATERIAL SPECIFICATIONS FOR THE AFFECTED BATCH. NEVERTHELESS, CONSIDERING THAT THE ROOT CAUSE IN UNDER INVESTIGATION AND THE POTENTIAL IMPACT OF SUCH UNITS CORRESPONDING TO THE AFFECTED BATCHES, BBSES DECIDES TO IMPLEMENT A CONTENTION MEASURE PROPOSING A RECALL OF THAT BATCHES AS BBSES ASSESSMENT INDICATES THAT THE RISK IS TOO HIGH TO KEEP SUCH UNITS IN THE MARKET. IN PARALLEL, A CAPA IS OPENED FOR FURTHER INVESTIGATION. FINAL CONCLUSION: CASSETTE RECEIVED FULFILLED RAW MATERIAL AND FINISHED PRODUCT SPECIFICATIONS. THEREFORE, AT THIS TIME WE CANNOT CONFIRM THE CASE UNTIL THE ROOT CAUSE IS IDENTIFIED. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: RECALL OF THIS CODE-BATCH FROM THE MARKET AS A CONTENTION MEASURE. CORRECTIVE/PREVENTIVE ACTIONS: A CAPA HAS BEEN OPENED.

    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THREAD BROKE. THE REPORTER INDICATED THE THREAD BROKE ON A TWO (2) YEAR OLD ANIMAL (COW) ONE-DAY POST-OPERATIVE CESAREAN SECTION. THE VETERINARIAN USED A CONTINUOUS SUTURE. THE ANIMAL DEVELOPED PERITONITIS. ANOTHER SURGERY WAS REQUIRED, THE UTERUS WAS SUTURED AGAIN, THE ABDOMEN WAS RINSED AND TREATMENT WITH ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICINE. THE CURRENT INFORMATION IS THE ANIMAL IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046807 CATGUT PLAIN 5 (9) 25M OTHER SUTURE GAL B.BRAUN SURGICAL SA F1144111 61818

    Patients

    Seq Age Sex Outcome Treatment
    1