BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRY GAUZE PREOPERATIVE SKIN PREP TRAY

    MDR report key: 2883930 · Received December 7, 2012

    Report

    Report Number
    MW5028253
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 5, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    OJU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTING VOLUNTARY AS A PT SAFETY CONCERN. IN THE DRY GAUZE PREOPERATIVE SKIN PREP TRAYS THERE ARE YELLOW SPONGE STICKS THAT ARE USED FOR VAGINAL PREPS IN OPERATING ROOM. THESE SPONGE STICKS ARE DESIGNED WITH A SLIT IN THE TOP. WHAT OPERATING ROOM STAFF AND SURGEONS ARE CONCERNED WITH IS WHEN THE SPONGE IS INSERTED INTO THE VAGINAL CAVITY THAT THE SPONGE PUSHES BACK EXPOSING THE PLASTIC STICK AND THIS HAS BEEN REPORTED TO CAUSE ABRASIONS OR LACERATIONS. IT WAS REPORTED THAT THESE TYPES OF EVENTS HAVE OCCURRED IN THE PAST. OPERATING ROOM STAFF STATED THAT A LACERATION OCCURRED TO THIS PT WITH THIS SPONGE STICK, BUT WAS UNABLE TO FIND ANY DOCUMENTATION. PT WENT HOME SAME DAY AS SURGERY. SURGEONS AND THE OPERATING ROOM STAFF ARE VOICING CONCERNS WITH THE DESIGN OF THIS DEVICE RELATED TO PT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRY GAUZE PREOPERATIVE SKIN PREP TRAY DRY GAUZE PREOPERATIVE SKIN PREP TRAY OJU CAREFUSION CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR