BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO GLIDESHEATH BASIC

    MDR report key: 3143255 · Received May 9, 2013

    Report

    Report Number
    3143255
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TERUMO RADIAL SHEATH WAS HAVING EPISODES OF AIR IN SIDE ARM AND SYRINGE WAS NOT LOCKING ONTO THE STOPCOCK. WHEN WIRE IN SHEATH, UNABLE TO GET BLEED BACK OR ASPIRATION FROM SIDE ARM OF SHEATH. WE HAVE HAD 2 INSTANCES AND PULLED ALL PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204921 TERUMO GLIDESHEATH BASIC TERUMO RADIAL SHEATH DYB TERUMO MEDICAL CORP. 130129 AND 130128

    Patients

    Seq Age Sex Outcome Treatment
    1