BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FUSOR 500ML PRESSURE INFUSOR

    MDR report key: 527977 · Received February 25, 2004

    Report

    Report Number
    1526863-2004-00009
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 29, 2004
    Manufacturer
    MEDEX
    Product Code
    KZD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT WHEN THEY ATTEMPTED TO USE THE PRODUCT IT WOULD NOT HOLD PRESSURE. THERE WAS NO PT TREATMENT OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FUSOR 500ML PRESSURE INFUSOR PRESSURE INFUSOR KZD MEDEX NA 32L200018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention