BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO NEEDLE

    MDR report key: 1472172 · Received June 23, 2009

    Report

    Report Number
    2242551-2009-00004
    Event Type
    Malfunction
    Date Received
    June 23, 2009
    Date of Event
    May 19, 2009
    Report Date
    June 23, 2009
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    FCG
    PMA / PMN Number
    K051506
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROSELOW INTRAOSSEOUS MODULE CONTAINS A LUER LOCK IV EXTENSION SET AND A 15 G INTRAOSSEOUS NEEDLE. A VENDOR CHANGE WAS MADE WHICH RESULTED IN THE USE OF A DIFFERENT 15G INTRAOSSEOUS NEEDLE. EVALUATION OF A SAMPLE FROM EXISTING INVENTORY HAS REVEALED THAT THE 15G INTRAOSSEOUS NEEDLE PROVIDED DOES NOT FIT SECURELY WITH THE IV EXTENSION SET THAT IS PROVIDED IN THE MODULE. THIS MAY RESULT IN A CONNECTION THAT IS NOT SECURE, COULD LEAK IN A CONNECTION THAT IS NOT SECURE, COULD LEAK AND/OR BECOME DISCONNECTED AND DELAY TREATMENT. AS A CORRECTIVE ACTION, WE HAVE REPLACED THE INTRAOSSEOUS NEEDLE FROM STERYLAB WITH ON PREVIOUSLY USED AND APPROVED MANUFACTURED BY CARDINAL HEALTH THAT HAS A SECURE AND PROPER CONNECTION. THE CARDINAL HEALTH NEEDLE IS COMPATIBLE WITH THE STANDARD LUER LOCKING FITTING ON THE IV EXTENSION SET IN THE MODULE.

    Description of Event or Problem · 1

    INTERROUS DEVICE LOCATED IN BROSELOW CARTS FOR PEDIATRIC PATIENTS. PATIENT PRESENTED IN A CODE SITUATION, COLOR CODED BROSELOW CART OPENED, IO NEEDLE PLACED FOR IV ACCESS. HUB OF IO NEEDLE RECESSED AND COULD NOT BE CONNECTED TO THE IV FLUIDS. ANOTHER IO WAS USED FROM THE NEXT COLOR UP, AND HAD THE CORRECT HUB WHICH WAS NOT RECESSED ALLOWING FOR CONNECTION. THE RISK MANAGER WAS NOTIFIED OF THE ISSUE ON 5/26/09.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IO NEEDLE BROSELOW IO MODULE FCG VITAL SIGNS, INC. NA 091K

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention