BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROM 5/0 (1.5) 75CM HR17

    MDR report key: 7166047 · Received January 4, 2018

    Report

    Report Number
    3003639970-2018-00008
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    November 23, 2017
    Report Date
    January 11, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    PMA / PMN Number
    K991223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: CHILE. THE LIQUID IS FILTERED TO PRESERVE THE SUTURE AND THE CONTAINER IS STAINED. SO THERE ARE SOME SUTURES WITH VERY LITTLE AMOUNT OF LIQUID INSIDE, WHICH IS DOUBTFUL OF THE CORRECT PRESERVATION OF THE SUTURE AND ITS STERILITY; ALSO THE LITTLE AMOUNT OF LIQUID MAKES THE CATGUT VERY RIGID AND MAKES ITS MANEUVERABILITY DIFFICULT.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: SAMPLES ARE NOT RECEIVED FOR RESEARCH, NEITHER ARE THE IMAGES OF THE AFFECTED LOT ANNEXED. PRELIMINARY ANALYSIS: STOCK REVIEW: ONCE THE STOCK WAS CHECKED, IT WAS VERIFIED THAT THERE ARE CURRENTLY NO UNITS OF THIS PRODUCT CODE AND LOT NUMBER. QUANTITY PRODUCED / IMPORTED: FROM THIS PRODUCT CODE AND BATCH NUMBER, 888 UNITS WERE PRODUCED IN TOTAL. BACKGROUND: PROCEED TO REVIEW THE DATABASE OF CLAIMS AND VERIFY THAT TO DATE THERE ARE NO REPORTS OF INCIDENTS, RELATED TO THIS PRODUCT CODE, LOT NUMBER AND CAUSE. BATCH RECORD / BATCH RECORD: A REVIEW OF THE DOCUMENTATION CORRESPONDING TO THE MANUFACTURING OF THE BATCH WAS MADE, IN WHICH THE CONTROL IN PROCESS AND CONTROL OF THE FINISHED PRODUCT WAS VERIFIED AND NO DEVIATIONS OR ALTERATIONS WERE IDENTIFIED DURING THE PROCESS. ANALYSIS OF THE SAMPLE (S): SAMPLES ARE NOT RECEIVED NOR THE IMAGES REQUESTED FROM THE CLIENT; IT MAY BE THAT THE DEFECT REPORTED HAS BEEN CAUSED BY A FAULT DURING THE MANUFACTURING PROCESS, ALTHOUGH IT IS NOT POSSIBLE TO IDENTIFY THE SITE WHERE THE LEAK OCCURS. THIS DEFECT HAS ALREADY BEEN IDENTIFIED AND THE NECESSARY CORRECTIVE MEASURES TAKEN AND TO DATE NO MORE REPORTS HAVE BEEN SUBMITTED FOR THIS REASON, WHICH SHOWS THAT THE ACTIONS WERE EFFECTIVE. CONCLUSIONS: THE CLAIM IS DETERMINED AS "CONFIRMED", GIVEN THAT THE BATCH WAS MANUFACTURED IN ADVANCE OF THE CORRECTIVE ACTIONS CREATED FOR THIS DEFECT, IT IS SUSPECTED THAT THE BATCH WAS AFFECTED. ACTIONS: NO ACTION IS REQUIRED, THE LEAK IS A DEFECT IDENTIFIED AND ADDRESSED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7014 CATGUT CHROM 5/0 (1.5) 75CM HR17 SUTURES GAL B.BRAUN SURGICAL SA B0560138 515152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other