BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAS LYTE QUIK A.B.G.

    MDR report key: 153436 · Received January 30, 1998

    Report

    Report Number
    153436
    Event Type
    Other
    Date Received
    January 30, 1998
    Date of Event
    November 25, 1997
    Report Date
    January 26, 1998
    Manufacturer
    MARQUEST/MED PROD, INC.
    Product Code
    CBT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    NEEDLE LEFT ON BLOOD GAS SYRINGE WITHOUT ANY TYPE OF SAFETY DEVICE. EMPLOYEE REACHED TO PICK UP SPECIMENS FROM A DUMBWAITER AND WAS STUCK WITH BARE NEEDLE. FOLLOW-UP REVEALED THAT PACKAGE INSERT DID NOT INCLUDE STATEMENT TO REMOVE NEEDLE AND REPLACE WITH SYRINGE CAP. FOLLOW-UP WITH PHYSICIAN WHO DID THIS REVEALED IT WAS NOT DONE BECAUSE THAT STEP WAS NOT INCLUDED IN DIRECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAS LYTE QUIK A.B.G. ARTERIAL BLOOD GAS COLLECTION KIT CBT MARQUEST/MED PROD, INC. * 10711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other