BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDSTREAM URINE COLLECTION KIT

    MDR report key: 3969951 · Received July 28, 2014

    Report

    Report Number
    3969951
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BARD MEDICAL
    Product Code
    OIE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    URINE SPECIMEN CONTAINER IN CATH KIT IS UNABLE TO TOLERATE BEING SENT BY THE PNEUMATIC TUBE SYSTEM WITHOUT FREQUENT LEAKAGE DUE TO CAP LOOSENING. PURCHASING HAS BEEN WORKING ON THIS, BUT HAS BEEN UNABLE TO OBTAIN AN IMPROVED PRODUCT. WHEN CAP LOOSENS, SPECIMEN CONTENTS ARE SPILLED INSIDE THE PNEUMATIC TUBE SHUTTLE, CREATING A BIO HAZARD EXPOSURE AND REQUIRING ANOTHER SPECIMEN TO BE OBTAINED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439924 MIDSTREAM URINE COLLECTION KIT URINE COLLECTION KIT (EXCLUDES HIV TESTING) OIE BARD MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *