BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1053572 · Received May 28, 2008

    Report

    Report Number
    1710034-2008-00065
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PREPAID MAILING LABEL AND TUBE WERE SENT TO THE CUSTOMER ON 21 MAY 2008 FOR THE RETURN OF THE SAMPLE. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.(B) (4)

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED AND WHEN ATTACHING TO THE TUBING THE NURSE NOTICED BLOOD AT THE SITE. THE NURSE THEN NOTED THAT THE CATHETER WAS MISSING. A DISSECTION WAS COMPLETED TO TRY TO RETRIEVE THE CATHETER FROM THE PT. THE CATHETER WAS LATER FOUND IN THE SAFETY CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA 7337498

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other