BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE POSITIVE BOLUS EXTENSION SET

    MDR report key: 1363309 · Received January 28, 2009

    Report

    Report Number
    9616066-2009-00059
    Event Type
    Malfunction
    Date Received
    January 28, 2009
    Report Date
    January 9, 2009
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION REQUESTED, AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    DATE OF EVENT IS UNKNOWN. DISTRIBUTOR REPORTED THAT END USER HEALIX REPORTED SET CAME UNGLUED FROM THE HUB PROXIMAL TO THE CONNECTION ON THE PICC LUMEN. THERE WAS NO HARM TO THE PT. DISTRIBUTOR HAS REQUESTED SET FROM HEALIX BUT DOES NOT KNOW IF SET WAS SAVED OR DISCARDED. FOLLOW-UP REPORT WILL BE FILED IF SET IS RECEIVED FOR INVESTIGATION IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE POSITIVE BOLUS EXTENSION SET FPA CARDINAL HEALTH ALARIS PRODUCTS 30049E 08095494

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK