BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFETY-T-CENTESIS CATHETER DRAINAGE TRAY

    MDR report key: 551988 · Received October 28, 2004

    Report

    Report Number
    1423507-2004-00109
    Event Type
    Other
    Date Received
    October 28, 2004
    Report Date
    October 28, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR WAS USING THE 5/8 SHARPS ENGINEERED SAFETY PROTECTION NEEDLE WITH LIDOCAINE PROVIDED IN THE KIT. AS DR WAS INJECTING THE PT THE NEEDLE AND ITS HUB UNDER PRESSURE HAD THE ORANGE ROUNDED NEEDLE HUB TWIST ITSELF OUT OF THE BODY OF THE ORANGE NEEDLE SAFETY DEVICE. THE PRESSURE FROM INJECTING CAUSED EVERYTHING TO SEPARATE AND SPRAY ALL AROUND THE AREA AND IN THE DOCTOR'S FACE. HE WAS WEARING A PROTECTIVE SHIELD HOWEVER IT SPRAYED UP UNDER THE SHIELD. ADDITIONALLY, DR STATED HE DID NOT HAVE A MOUTH SHIELD ON UNDER THE FACE SHIELD. DR FURTHER STATED; HE HOOKED THE LIDOCAINE UP TO THE NEEDLE WITH SAFETY HUB AND IT SEPARATED OR BROKE. HE DECDED NOT TO GO THROUGH SIX MONTHS OF MEDICATION, BUT WILL BE TESTED FOR HIV LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY-T-CENTESIS CATHETER DRAINAGE TRAY DIAGNOSTIC KITS/TRAYS GCB CARDINAL HEALTH PIG1260T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other