BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 5 (9) 25M

    MDR report key: 9536296 · Received December 31, 2019

    Report

    Report Number
    3003639970-2019-00943
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Report Date
    March 13, 2020
    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: 3 CLOSED CASSETTES AND 2 OPENED. ANALYSIS AND RESULTS: THERE ARE TWO PREVIOUS CASES OF THIS CODE-BATCH REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) 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 3 CLOSED AND 2 OPEN CASSETTES FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENT OF THE B. BRAUN SURGICAL (BBS REQUIREMENT: [?]9.00 KGF IN AVERAGE). THERE ARE NO EP/USP LIMITS FOR THIS SIZE. RESULTS FOR THE CLOSED CASSETTES: 14.27 KGF, 13.87 KGF AND 13.63 KGF IN AVERAGE. RESULTS FOR THE OPEN CASSETTES: 13.50 KGF AND 13.25 KGF IN AVERAGE. THE CASSETTES RECEIVED FULFILS THE FINISHED PRODUCT SPECIFICATIONS AND RAW MATERIAL SPECIFICATIONS FOR THE INVOLVED BATCH. NEVERTHELESS, CONSIDERING THAT THE ROOT CAUSE IS UNDER INVESTIGATION AND THE POTENTIAL IMPACT OF SUCH UNITS CORRESPONDING TO THE INVOLVED BATCH, BBSES DECIDED TO IMPLEMENT A CONTENTION MEASURE PROPOSING A RECALL OF THAT BATCH AS BBSES ASSESSMENT INDICATED THAT THE RISK IS TOO HIGH TO KEEP SUCH UNITS IN THE MARKET. IN PARALLEL, A CAPA WAS OPENED FOR FURTHER INVESTIGATION. FINAL CONCLUSION: CASSETTES 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.

    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. NO CODE AVAILABLE 3191 (VETERINARY CASE). IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD BROKE AFTER SURGERY. THE REPORTER INDICATED THAT A VETERINARY CASE (COW) REQUIRED A CESAREAN SECTION. THE UTERUS WAS SUTURED USING THE CATGUT. THE PERITONEUM WAS SUTURED WITH VICRYL AND THE SKIN WAS SUTURED WITH SUPRAMID WHITE. ONE TO TWO DAYS POST-OPERATIVE THE COW DEVELOPED COMPLICATIONS: NOT EATING, GAS INSIDE ABDOMEN AND PERITONITIS. VIA RECTAL EXPLORATION, IT WAS NOTED THE ANIMAL HAD A TEMPERATURE OF 40 DEGREES CELSIUS. MEASURES TAKEN BY THE SURGEON: THE CATGUT WAS REPLACED WITH ANOTHER CATGUT. PER THE REPORTER THE CONSEQUENCES OF THE INCIDENT: THE ANIMAL WAS SICK WITH PERITONITIS AND NOT ABLE TO INSEMINATE AGAIN. THE ANIMAL DIED SEVEN DAYS POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329112 CATGUT PLAIN 5 (9) 25M OTHER SUTURE GAL B.BRAUN SURGICAL SA F1144111 618185

    Patients

    Seq Age Sex Outcome Treatment
    1