BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV TUBING, 100 ML/HR

    MDR report key: 10948 · Received January 13, 1994

    Report

    Report Number
    MW1000387
    Event Type
    Malfunction
    Date Received
    January 13, 1994
    Report Date
    January 12, 1994
    Manufacturer
    I-FLOW CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    LEAKAGE WAS NOTED FROM THE LUER-LOCK TUBING JUNCTION. THE TUBING IS USED WITH THE INFUSION SYSTEM. (ALSO SEE 1000386.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV TUBING, 100 ML/HR FPA I-FLOW CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *