BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIFIX

    MDR report key: 4365541 · Received December 19, 2014

    Report

    Report Number
    9610825-2014-00462
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Report Date
    October 30, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMF
    PMA / PMN Number
    K63280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE (B)(4) ORIGINAL PACKED OMNIFIX 20 ML WERE ASSIGNED. THE SAMPLES WERE VISUALLY TESTED FOR DAMAGES ACCORDING TO THE TEST METHOD. WE DETECTED THAT EVERY SAMPLE HAS A CRACK AT THE PAPER FOIL IN THE UPPER AREA. MOREOVER, WE DETECTED THAT THE CAVITY OF THE PLASTIC FOIL IS NOT CENTERED, IT IS SHIFTED UPWARD. THE SAMPLES ARE NOT WITHIN THE SPECIFICATION. THIS DEFECT HAS NOT BEEN DETECTED AT ANY OTHER COMPLAINT. AN INSPECTION OF THE RETENTION SAMPLES OF PREVIOUS AND FOLLOWING BATCHES CONFIRMED THAT ONLY THIS BATCH WAS AFFECTED. CAPA (B)(4) WAS INITIATED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(4)); WHEN AN EXTERNAL COMPANY FOR SORTATION CHECKED IN ORDER OF B. BRAUN (B)(4) SYRINGES, (B)(4) DAMAGED SINGLE UNIT PACKAGES WERE FOUND. IT WAS DECIDED TO INFORM CUSTOMERS AND TO RECALL THE BATCH. RECALL AFFECTS ONLY COUNTRIES WITHIN EUROPE/ EUROPEAN UNION, THE BATCH WAS NOT DISTRIBUTED WITHIN THE USA OR CANADA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838481 OMNIFIX HYPODERMIC SYRINGE FMF B. BRAUN MELSUNGEN AG NA 4H11048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK