BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ESWAB COLLECTION KIT REGULAR FLOCKED SWAB

    MDR report key: 9652753 · Received January 31, 2020

    Report

    Report Number
    9652753
    Event Type
    Malfunction
    Date Received
    January 31, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 2, 2020
    Manufacturer
    COPAN ITALIA
    Product Code
    JTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONCERN HAS ARISEN AROUND THE USE OF THE BECTON DICKINSON THROAT SWAB. THIS SWAB IS MANUFACTURED BY (B)(4) AND DISTRIBUTED BY BECTON DICKINSON. THE CONCERN IS THAT THERE IS A PRE-MANUFACTURED "BREAK AWAY" AREA ALONG THE SHAFT OF THE SWAB TO ALLOW THE CLINICIAN TO BREAK OFF THE TIP, PUT IT IN THE VIAL THAT COMES IN THE PACKAGE, AND SEND THE VIAL TO THE LAB FOR TESTING. THE CONCERN IS THAT THE TIP COULD BREAK OFF WHILE IN USE, ESPECIALLY WHEN SWABBING A CHILD'S THROAT. A CHILD COULD EASILY BITE DOWN ON THE SWAB SHAFT CAUSING IT TO BREAK IN THE PREDETERMINED AREA AND POSSIBLY GET STUCK IN THE CHILD'S THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118358 BD ESWAB COLLECTION KIT REGULAR FLOCKED SWAB SYSTEM, TRANSPORT, AEROBIC JTW COPAN ITALIA 220245

    Patients

    Seq Age Sex Outcome Treatment
    1