BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-SIDEPORT CATHETER INFUSION SET

    MDR report key: 125846 · Received October 14, 1997

    Report

    Report Number
    1820334-1997-00139
    Event Type
    Injury
    Date Received
    October 14, 1997
    Date of Event
    September 11, 1997
    Report Date
    September 15, 1997
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD SWELLING (THROMBUS) IN THE LEFT ARM. THE CATHETER INFUSION SET WAS PLACED IN THE BASILIC VEIN FOR INFUSION PURPOSES. THEY DID NOT FLUORO AFTER CATHETER TIP OCCLUDER PLACEMENT. THE PT WAS SENT TO ICU FOR UROKINASE TREATMENT. THE FOLLOWING DAY, SHE HAD SWELLING IN THE NECK AND CHEST PAINS. DYE WAS INJECTED AND IT WAS FOUND THE CATHETER TIP OCCLUDER HAD WENT OUTSIDE OF THE LUMEN VESSEL AND WAS EXTRAVASCULAR. THE DEVICE WAS SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-SIDEPORT CATHETER INFUSION SET CATHETER INFUSION SET DQO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention