BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABG MICRO 1ML 25 GAUGE 5/8" SL

    MDR report key: 5679027 · Received May 25, 2016

    Report

    Report Number
    8030673-2016-00172
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 18, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBT
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WAS RECEIVED FOR EVALUATION. HOWEVER BASED ON SIMILAR COMPLAINTS THE PART NUMBER 070-2080305 (LOCKING CLASP) WAS MISSING ON THE ASSEMBLY INSTRUCTIONS WHEN THE DEVICE HISTORY RECORD WAS REVIEWED, THEREFORE THE ISSUE REPORTED WAS CONFIRMED. TO CORRECT THIS ISSUE GOING FORWARD, THE LIST FOR ASSEMBLY WAS UPDATED TO INCLUDE THIS COMPONENT. IN ADDITION, A VISUAL AID WAS IMPLEMENTED TO HELP PRODUCTION PERSONNEL WHEN ASSEMBLING THIS PRODUCT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "ON (B)(6) I WAS DRAWING A BLOOD GAS. WHEN I PLACED THE SYRINGE IN THE ORANGE STOPPER, THE SHARP CAME BACK OUT WITH IT. I FOUND THIS ODD AND SIMPLY DISCONNECTED THE NEEDLE AND PLACED IT BACK IN THE STOPPER. I DIDN'T THINK MUCH OF IT AND THOUGHT IT WAS PROBABLY AN ISOLATED INCIDENT. THE KITS ARE MISSING THE SUR LOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332502 ABG MICRO 1ML 25 GAUGE 5/8" SL KIT, SAMPLING, ARTERIAL BLOOD CBT CAREFUSION, INC 884993

    Patients

    Seq Age Sex Outcome Treatment
    1