BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET

    MDR report key: 1350838 · Received January 21, 2009

    Report

    Report Number
    9616066-2009-00036
    Event Type
    Malfunction
    Date Received
    January 21, 2009
    Report Date
    December 30, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED, AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    DATE OF EVENT IS UNK. PHARMACY MANAGER REPORTED THAT SET LEAKED FROM SOFT PART OF TUBING (SILICONE PUMPING SEGMENT) DURING USE WITH UNSPECIFIED CHEMO. STATED LEAK OCCURRED DURING INFUSION VIA PUMP, NOT DURING PRIMING. SET NOT RECEIVED YET. FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION IS COMPLETE IF SET IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMINISTRATION SET FPA CARDINAL HEALTH ALARIS PRODUCTS 2200-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK