BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-T-CLICK

    MDR report key: 28500 · Received December 5, 1995

    Report

    Report Number
    MW1007842
    Event Type
    Injury
    Date Received
    December 5, 1995
    Date of Event
    November 29, 1995
    Report Date
    December 4, 1995
    Manufacturer
    RYAN MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PROTECTED NEEDLE WAS ALLOWING BLOOD TO FLOW OUT; THEREFORE THE PT LOST AT LEAST 2 CC OF BLOOD AT ONCE. THIS CHILD IS BORDERLINE HYPOBOLEMIC & ALSO HAS ANEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-CLICK PROTECTED NEEDLE ADAPTER FOZ RYAN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Life Threatening| R