BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-300 IV ADMINISTRATION SET

    MDR report key: 5327213 · Received September 1, 2004

    Report

    Report Number
    1221261-2004-00030
    Event Type
    Malfunction
    Date Received
    September 1, 2004
    Date of Event
    August 1, 2004
    Report Date
    August 5, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH MEDICAL ASD, INC. IS UNABLE TO FULLY EVALUATE THIS REPORT. THE USER FACILITY DISPOSED OF THE SET THAT WAS USED DURING THE INFUSION OF BLOOD. IN ADDITION, NO LOT NUMBER WAS OBTAINED FOR THE DEVICE HISTORY RESEARCH. THE USER FACILITY REPORTED THAT THE USER DID NOT CHECK THE CONNECTIONS DURING SETUP OF THE TUBING, NOR WAS THE CAP TIGHTENED AT ALL. THIS IS REGULAR STANDARD OF CARE PRACTICE AND THE HOSPITAL WILL ADDRESS STAFF SPECIFICALLY EMPHASIZING THEY SECURE ALL TUBING CONNECTIONS DURING SETUP.

    Description of Event or Problem · 1

    USER ALLEGES THAT THE CAP ON THE INJECTION SITE, ABOVE THE HEAT EXCHANGER, BLEW OFF AND BLOOD WAS EJECTED ON THE FLOOR AND PERSONNEL. THERE WAS NO INJURY TO PT OR CLINICIAN REPORTED. SMITHS MEDICAL ASD, INC. COMPLAINT NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-300 IV ADMINISTRATION SET IV ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. D-300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1