BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROMIC 2/0 (3.5) 100M

    MDR report key: 7542158 · Received May 24, 2018

    Report

    Report Number
    3003639970-2018-00316
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Report Date
    July 17, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: 1 CASSETTE. ANALYSIS AND RESULTS: THERE IS A PREVIOUS COMPLAINT REGARDING ANOTHER ISSUE BUT RELATED (THREAD TANGLED IN CASSETTE). (B)(4) UNITS OF THIS CODE BATCH WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN CASSETTE WITH THE THREAD BROKEN INSIDE THE CASSETTE. THE THREAD WAS PROBABLY TANGLED IN THE REEL AND WHEN PULLING OUT THE THREAD IT BROKE DUE TO THE EXTRACTION WAS TOO HARD/DIFFICULT. 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 THE RESULTS OF SAMPLE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. 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.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: SOUTH KOREA. IT WAS REPORTED THAT THE THREAD BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385080 CATGUT CHROMIC 2/0 (3.5) 100M SUTURES GAL B.BRAUN SURGICAL SA F1154052 616444

    Patients

    Seq Age Sex Outcome Treatment
    1 Other