BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL CULTURE SWAB

    MDR report key: 1421096 · Received July 13, 2009

    Report

    Report Number
    1421096
    Event Type
    Malfunction
    Date Received
    July 13, 2009
    Date of Event
    June 30, 2009
    Report Date
    July 13, 2009
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING Q-TIP TO CULTURE WOUND THROUGH AN ARTHROSCOPY INCISION. AFTER INSERTION INTO INCISION, SURGEON USED TWILLING MOTION ON Q-TIP HANDLE. AS THE SURGEON WAS ATTEMPTING TO REMOVE THE Q-TIP, ABOUT AN INCH OF TIP BROKE OFF INTO INCISION. SURGEON LOOKED FOR THE Q-TIP AND HAD TO MAKE THE INCISION BIGGER TO DEBRIDE THE TISSUE AND REMOVE THE Q-TIP.

    Description of Event or Problem · 1

    SURGEON WAS USING Q-TIP TO CULTURE WOUND THROUGH AN ARTHROSCOPY INCISION. AFTER INSERTION INTO INCISION, SURGEON USED TWILLING MOTION ON Q-TIP HANDLE. AS THE SURGEON WAS ATTEMPTING TO REMOVE THE Q-TIP, ABOUT AN INCH OF TIP BROKE OFF INTO INCISION. SURGEON LOOKED FOR THE Q-TIP AND HAD TO MAKE THE INCISION BIGGER TO DEBRIDE THE TISSUE AND REMOVE THE Q-TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL CULTURE SWAB CULTURE & TRANSPORT SYSTEM JSL BECTON DICKINSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR