BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABG

    MDR report key: 341439 · Received June 29, 2001

    Report

    Report Number
    1718887-2001-00003
    Event Type
    Other
    Date Received
    June 29, 2001
    Date of Event
    May 11, 2001
    Report Date
    June 29, 2001
    Manufacturer
    MARQUEST MEDICAL PRODUCTS
    Product Code
    CBT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT THE N EEDLE PIERCED THROUGH THE SIDE OF THE SURE-LOK NEEDLE PROTECTION DEVICE. INITIAL REPORT INDICATED THAT NO PATIENT OR HEALTH CARE WORKER INJURY. DURING EXAMINATION IN 2001, INVESTIGATOR, (EMPLOYEE) WAS STUCK WITH THE NEEDLE WHICH WAS EXTENDED OUTSIDE THE PROTECTION DEVICE. WHEN HOSPITAL WAS CONTACTED VERBALLY REPORTED THAT A CLINICIAN WAS STUCK WITH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29795 ABG ARTERIAL BLOOD GAS KIT CBT MARQUEST MEDICAL PRODUCTS 4522TRU 942L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other