BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 3/0 (3) 75CM DS24

    MDR report key: 3823585 · Received February 28, 2014

    Report

    Report Number
    2916714-2014-00110
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    November 6, 2013
    Report Date
    February 25, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON 02/05/2014. REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, SIMILAR DEVICE IS. MFG SITE EVAL: (B)(4) SUTURE REC'D IN CLOSE PACKAGING. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE / BATCH. THE (B)(4) UNITS OF THIS CODE BATCH WERE MANUFACTURED AND DISTRIBUTED, THERE ARE 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 REC'D WERE SUBJECTED TO A VISUAL INSPECTION WHICH SHOWS THAT THE SUTURE PACKAGE DOES NOT CONTAIN STERILIZING SOLUTION, BECAUSE OF A FAILURE DURING THE MFG PROCESS, WHICH COULD NOT BE IDENTIFIED AT THE TIME OF PRODUCT RELEASE, ONLY AFTER SOME TIME. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: CORRECTIVE ACTION WAS INITIATED IN 2012. THIS CORRECTIVE ACTION HAS BEEN FULLY IMPLEMENTED AND A MEASURE OF THE EFFECTIVENESS HAS BEEN COMPLETED. THIS CORRECTIVE ACTION IS CLOSED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SUTURE LOST LIQUID DURING STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124309 CATGUT PLAIN 3/0 (3) 75CM DS24 NONE GAM B. BRAUN SURGICAL S.A. B0532363 5-9395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other