BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN

    MDR report key: 971854 · Received December 22, 2007

    Report

    Report Number
    2031921-2007-00042
    Event Type
    Malfunction
    Date Received
    December 22, 2007
    Report Date
    December 4, 2007
    Manufacturer
    CURLIN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A DISPOSABLE ADMINISTRATION SET, USED WITH A CURLIN INFUSION PUP, LEAKED AT A TUBING CONNECTION. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FPA CURLIN MEDICAL, INC. 340-4115 D714243

    Patients

    Seq Age Sex Outcome Treatment
    1 YR