BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BRAND NEEDLES

    MDR report key: 2082759 · Received April 29, 2011

    Report

    Report Number
    1710034-2011-00033
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 29, 2011
    Product Code
    FMI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IDENTIFIED BY THE CUSTOMER IS LISTED ON THE PRODUCT RECALL NOTIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING BLOOD COLLECTION, BLOOD STARTED LEAKING FROM THE DEVICE BEING USED. THE PHLEBOTOMIST ACTIVATED THE PUSH BUTTON AND THE NEEDLE (CANNULA) STAYED IN THE PATIENT'S ARM. THE CANNULA WAS REMOVED WITHOUT CAUSING ANY HARM TO THE PATIENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED FOR THE PATIENT OR THE PHLEBOTOMIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER BRAND NEEDLES PUSH BUTTON BLOOD COLLECTION SETS FMI NA 0354635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other