BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERO-MED URINE COLLECTION KIT

    MDR report key: 7613839 · Received June 19, 2018

    Report

    Report Number
    7613839
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 6, 2018
    Manufacturer
    AERO-MED, LTD.
    Product Code
    OIB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE WAS TRANSFERRING URINES, USING THE URINE TRANSFER CUP. SHE WENT TO PUT THE RED AND YELLOW TOP TUBE ONTO THE EXPOSED NEEDLE PORTION OF THE CUP, AND THE NEEDLE PART GOT STUCK INSIDE THE TUBE. THE DEVICE HAS BEEN DISCARDED. NO PATIENT/EMPLOYEE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459618 AERO-MED URINE COLLECTION KIT BLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING) OIB AERO-MED, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1