BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1289465 · Received January 13, 2009

    Report

    Report Number
    1710034-2008-00167
    Event Type
    Other
    Date Received
    January 13, 2009
    Report Date
    December 17, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND LOT NUMBER INVOLVED IS 7241253, CATALOG NUMBER 381412, EXP. DATE 09/30/2010, MFG DATE 08/2007. A PREPAID TUBE AND LABEL WERE SENT TO THE CUSTOMER FOR THE RETURN OF THE SAMPLE. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE NURSE SAID THE PT FELT A BURNING HOT SENSATION OVER SHOULDERS FOLLOWED BY DIZZINESS, AND THEN WENT PALE. SYMPTOMS RESOLVED IN 20 MINS. A COUPLE WEEKS LATER, SHE HAD ANOTHER CATHETER INSERTED AND SAME SYMPTOMS APPEARED AS BEFORE, BUT MORE SEVERE. THE NURSE SAID THE PT HAS HAD MULTIPLE REACTIONS WITH DIFFERENT CATHETERS, BUT DIDN'T KNOW ANY OTHER SPECIFICS ABOUT THOSE. (B) (4) AND (B) (4).

    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 NA 7305560

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other