BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 3/0 (3) 75CM HR26

    MDR report key: 3982748 · Received June 16, 2014

    Report

    Report Number
    2916714-2014-00454
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 16, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAL
    PMA / PMN Number
    K991223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(6)2014. MFG SITE EVAL: SAMPLES RECEIVED: WE RECEIVED 14 SUTURES OF CATGUT SIMPLE 3/0 (3) HR26 75CM IN CLOSED PACKAGING. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE / BATCH. NO UNITS IN OEM STOCK. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. THE SAMPLES RECEIVED WERE SUBJECTED TO A VISUAL INSPECTION WHICH SHOWS THAT THE SUTURES ARE NOT STERILIZING SOLUTION, BECAUSE OF A FAILURE DURING THE MFG PROCESS, WHICH CAN NOT BE IDENTIFIED AT THE TIME OF PRODUCT RELEASE, ONLY AFTER SOMETIME. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: CORRECTIVE ACTION HAS BEEN IMPLEMENTED AND EFFECTIVENESS CHECKS COMPLETE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). NO LIQUID IN CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353478 CATGUT PLAIN 3/0 (3) 75CM HR26 SUTURE GAL B. BRAUN SURGICAL S.A. B0530425 511262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other