BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAT CODE = P103020 HUBER NEEDLE

    MDR report key: 746498 · Received August 31, 2005

    Report

    Report Number
    MW1036507
    Event Type
    Malfunction
    Date Received
    August 31, 2005
    Date of Event
    August 25, 2005
    Report Date
    August 25, 2005
    Manufacturer
    KAWASUMI LABORATORIES
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT INFUSING 5FU, PRODUCT LEAKED. RN REMOVED HUBER NEEDLE. THE HUB WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAT CODE = P103020 HUBER NEEDLE NEEDLE 226 X 3/4" / MICROBORE TUBING FMI KAWASUMI LABORATORIES * 4222P3

    Patients

    Seq Age Sex Outcome Treatment
    1 *