BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 3/0 (3) 75CM HR26

    MDR report key: 7166043 · Received January 4, 2018

    Report

    Report Number
    3003639970-2018-00009
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    November 23, 2017
    Report Date
    January 12, 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: NO SAMPLES ARE RECEIVED FOR THE INVESTIGATION; ATTACHED IMAGE OF THE POSTERIOR PACKAGING OF THE REPORTED SUTURE IS ATTACHED. PRELIMINARY ANALYSIS: · STOCK REVIEW: WE PROCEED TO REVIEW THE AVAILABLE UNITS OF THIS PRODUCT CODE AND LOT NUMBER, EVIDENCING THAT TO DATE THERE ARE NO AVAILABLE UNITS IN OUR STOCK. · PRODUCED / IMPORTED QUANTITY: FROM THIS PRODUCT CODE AND BATCH NUMBER, (B)(4) UNITS IN TOTAL WERE MANUFACTURED IN BBMCO. · 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 WERE VERIFIED. NO DEVIATIONS OR ALTERATIONS ARE IDENTIFIED DURING THE PROCESS. ANALYSIS OF THE SAMPLES: THE RECEIVED IMAGE CORRESPONDS TO THE REPORTED LOT; IT WAS VERIFIED VISUALLY AND IT IS EVIDENT THAT THE OUTER PACKAGING PRESENTS SPOTS, CAUSED BY THE LEAKAGE OF THE STERILIZING SOLUTION; IT MAY BE THAT THE DEFECT REPORTED HAS BEEN 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 HAVE BEEN EFFECTIVE. CONCLUSIONS: THE CLAIM IS DETERMINED AS "CONFIRMED", SINCE THE ATTACHED IMAGE SHOWS THAT IT DOES NOT MEET THE SPECIFICATIONS FOR THIS TYPE OF SUTURE. 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
    7009 CATGUT PLAIN 3/0 (3) 75CM HR26 SUTURES GAL B.BRAUN SURGICAL SA B0530425 515092

    Patients

    Seq Age Sex Outcome Treatment
    1 Other