BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CULTURETTE

    MDR report key: 46092 · Received September 18, 1996

    Report

    Report Number
    1119779-1996-00001
    Event Type
    Malfunction
    Date Received
    September 18, 1996
    Date of Event
    July 17, 1996
    Report Date
    September 12, 1996
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEMS
    Product Code
    JSC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLEDGET ADHERED TO SWAB PRIOR TO USE. WHILE COLLECTING A THROAT CULTURE, THE PLEDGET BECAME DETACHED FROM THE SWAB AND LODGED IN THE PT'S THROAT. THE MD REMOVED THE PLEDGET WITH HIS FINGER.

    Description of Event or Problem · 2

    PLEDGET ADHERED TO SWAB PRIOR TO USE. WHILE COLLECTING A THROAT CULTURE, THE PLEDGET BECAME DETACHED FROM THE SWAB AND LODGED IN THE PT'S THROAT. THE MD REMOVED THE PLEDGET WITH HIS FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CULTURETTE COLLECTION & TRANSPORT SYSTEM JSC BECTON DICKINSON MICROBIOLOGY SYSTEMS NA 605045

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other
    2 UNKNOWN