BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILOC SAFETY INFUSION SET

    MDR report key: 1040315 · Received May 8, 2008

    Report

    Report Number
    MW5006766
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 8, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BARD MINILOC SAFETY INFUSION SET 22G X 0.75IN. LOT #ASSBS003. PORT A CATH HUBER NEEDLE SAFETY FAILED TO LOCK IN PLACE UPON REMOVAL FROM PT. SECOND NEEDLE, WING FOR REMOVING PULLED OFF WHILE HOLDING. ABLE TO RECREATE THE FAILURE OF THE SAFETY LOCK WITH ANOTHER NEEDLE FROM THIS LOT. SAFETY "CLICK" AND "COLOR CHANGE" OCCURRED, BUT DID NOT STAY IN PLACE, NEEDLE WAS NOT LOCKED IN A SAFE MANNER. DUE TO PRODUCT FAILING TO LOCK AS IT SHOULD, RN EXPERIENCED CONTAMINATED NEEDLE STICK, EXPOSURE TO BLOOD BORNE PATHOGENS, REQUIRED MEDICAL TREATMENT AND EVALUATION. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: PORT A CATH ACCESS FOR CHEMO ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILOC SAFETY INFUSION SET HUBER NEEDLE FPA BARD ACCESS SYSTEMS 0632234 ASSBS003

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability