BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS CLAVE PORT EXT 7"

    MDR report key: 607883 · Received May 23, 2005

    Report

    Report Number
    9615050-2005-00099
    Event Type
    Malfunction
    Date Received
    May 23, 2005
    Date of Event
    January 1, 2005
    Report Date
    May 2, 2005
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF TUBING RUPTURE DURING USE WITH A POWER INJECTOR. IT WAS REPORTED THE MALLINCKRODT POWER INJECTOR WAS SET AT AN UNSPECIFIED PSI TO INFUSE AN UNSPECIFIED AMOUNT OF OPTIRAY 320 CONTRAST AT A RATE OF 4ML/SECOND. AT AN UNSPECIFIED TIME DURING THE INJECTION, THE TUBING RAPTURED. IT WAS REPORTED THAT THE EVENT CAUSED A "BIG MESS, A DELAY IN THE STUDY, AND ADDED RADIATION EXPOSURE FOR THE PT". THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS CLAVE PORT EXT 7" ADMINISTRATION SET FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other