BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QTEST STREP 40 TEST KIT

    MDR report key: 96373 · Received June 3, 1997

    Report

    Report Number
    1119779-1997-00007
    Event Type
    Malfunction
    Date Received
    June 3, 1997
    Date of Event
    May 7, 1997
    Report Date
    May 30, 1997
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TIP OF SWAB CAME OFF IN PATIENT'S THROAT. TIP WAS SUCCESSFULLY REMOVED. NO DEATH OR SERIOUS INJURY HAS OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QTEST STREP 40 TEST KIT STREP DETECTION GTY BECTON DICKINSON MICROBIOLOGY SYSTEMS NA 38004760

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention