BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 6 (10) 25M D2

    MDR report key: 9536297 · Received December 31, 2019

    Report

    Report Number
    3003639970-2019-00944
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Report Date
    March 16, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: TWO OPEN AND USED CASSETTES. 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 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 TWO OPEN AND USED 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: >11.50 KGF IN AVERAGE). THERE ARE NO EP/USP LIMITS FOR THIS SIZE. RESULTS FOR THE OPEN CASSETTES: 13.91 KGF AND 13.94 KGF IN AVERAGE. THE CASSETTES RECEIVED FULFILS THE FINISHED PRODUCT SPECIFICATIONS AND RAW MATERIAL SPECIFICATIONS FOR THE INVOLVED BATCH. THE INVESTIGATION OF THE ROOT CAUSE IS STILL UNDER INVESTIGATION. NEVERTHELESS, CONTINUING WITH THE ROOT CAUSE INVESTIGATION OF THE CAPA OPENED, CONSIDERING 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. 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. A CORRECTIVE/PREVENTIVE HAS BEEN INITIATED.

    Additional Manufacturer Narrative · 0

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

    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. TWO DAYS POST-OPERATIVE THE COW DEVELOPED COMPLICATIONS: NOT EATING, PERITONITIS AND A HOLE IN THE UTERUS (WHICH WAS NOTICED VIA RECTAL PALPATION). MEASURES TAKEN BY THE SURGEON: THE CATGUT WAS REPLACED WITH VICRYL. THE COW WAS TREATED WITH ANTIBIOTICS. PER THE REPORTER THE CONSEQUENCES OF THE INCIDENT: IT IS UNKNOWN IF THE ANIMAL CAN BECOME PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329114 CATGUT PLAIN 6 (10) 25M D2 OTHER SUTURE GAL B.BRAUN SURGICAL SA F1144120 619155

    Patients

    Seq Age Sex Outcome Treatment
    1