BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABG MICRO 1ML 25 GAUGE 5/8" SL

    MDR report key: 5679049 · Received May 25, 2016

    Report

    Report Number
    8030673-2016-00171
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 11, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBT
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED FROM THE CUSTOMER AND IS IN THE PROCESS OF BEING EVALUATED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE OR WHEN THE SAMPLE EVALUATION IS COMPLETE A FOLLOW UP EMDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN UNOPENED REPRESENTATIVE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED COMPLAINT DEVICE AND IT WAS OBSERVED THAT THE LOCKING CLASP (PART NUMBER 070-2080305) WAS CONFIRMING THE CUSTOMER¿S REPORTED ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE AN INCORRECT BILL OF MATERIALS (BOM); THE COMPONENT (LOCKING CLASP) WAS NOT LISTED ON THE BOM. A CORRECTIVE ACTION WAS IMPLEMENTED TO UPDATE THE BOM 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 THAT THE ABG KITS DO NOT HAVE THE SUR LOCK. (B)(6) SAID SHE CAME CLOSE TO GETTING A NEEDLE STICK. CUSTOMER REPORTED "ON (B)(6) I WAS DRAWING A BLOOD GAS. I PLACED IN THE SYRINGE IN THE STOPPER AND THEN APPLIED PRESSURE TO THE PATIENT AND BANDAGED THE SITE. I THEN REMOVED THE SYRINGE FROM THE ORANGE SHARPS STOPPER WITH ONE HAND AND HAD THE BLACK STOPPER IN THE OTHER HAND TO APPLY TO THE END OF THE SYRINGE. AS I WAS DOING THIS I NOTICED THE NEEDLE STILL ATTACHED AS IT WAS ONLY PERHAPS HALF AN INCH FROM MY HAND HOLDING THE BLACK STOPPER. I THEN RETURNED IT TO THE ORANGE SHARPS STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335025 ABG MICRO 1ML 25 GAUGE 5/8" SL KIT, SAMPLING, ARTERIAL BLOOD CBT CAREFUSION, INC 884993

    Patients

    Seq Age Sex Outcome Treatment
    1