BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 0 (4) 75CM HR43

    MDR report key: 7166038 · Received January 4, 2018

    Report

    Report Number
    3003639970-2018-00005
    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

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: SAMPLES ARE NOT RECEIVED FOR THE INVESTIGATION, ONLY A POSTERIOR IMAGE OF THE OUTER ENVELOPE OF THE SUTURE. PRELIMINARY ANALYSIS: · STOCK REVIEW: WE PROCEED TO REVIEW THE AVAILABLE UNITS OF THIS PRODUCT CODE AND LOT NUMBER AND VERIFY THAT TO DATE THERE ARE NO UNITS IN STOCK. · QUANTITY PRODUCED / IMPORTED: OF THIS PRODUCT CODE AND BATCH NUMBER, (B)(4) 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 AND LOT NUMBER SINCE ITS MANUFACTURE IN 2013. · 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): IN THE IMAGE RECEIVED FROM THE CLAIMED SUTURE, THE FRONT PART CAN NOT BE SEEN; THE POSTERIOR PART IS EVIDENT, THE MEDICAL GRADE PAPER OF THE ENVELOPE IS POSSIBLY STAINED BY THE STERILIZING SOLUTION; IT MAY BE THAT THIS DEFECT WAS CAUSED BY A FAULT DURING THE MANUFACTURING PROCESS. 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: ACCORDING TO THE IMAGE RECEIVED FROM THE REPORTED LOT, THE CLAIM IS DETERMINED AS "JUSTIFIED". ACTIONS: NO ACTION IS REQUIRED, THE LEAK IS A DEFECT IDENTIFIED AND ADDRESSED IN CAPA (B)(4)

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7286 CATGUT PLAIN 0 (4) 75CM HR43 SUTURES GAL B.BRAUN SURGICAL SA B0530573 513512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other