BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO BLOOD COLLECTION NEEDLE

    MDR report key: 2308391 · Received September 12, 2011

    Report

    Report Number
    1056186-2011-00002
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K992699
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHED IS THE INITIAL INVESTIGATION REPORT OF SAME LOT OF PRODUCT. SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. AFTER RECEIPT OF SAMPLE, THE INVESTIGATION WILL CONTINUE AND SUBSEQUENT REPORT SENT TO FDA.

    Description of Event or Problem · 1

    RUBBER SLEEVE NOT RETRACTING OVER NEEDLE AFTER BLOOD COLLECTION TUBE IS REMOVED. CLINICIAN CAME IN CONTACT WITH BLOOD AS A RESULT. CLINICIAN WAS WEARING PROTECTIVE GEAR, NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE FMI NIPRO MEDICAL CORPORATION NM+21G25 11A08

    Patients

    Seq Age Sex Outcome Treatment
    1