BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR NON-VALVED THORA/PARA TRAY

    MDR report key: 9821092 · Received March 11, 2020

    Report

    Report Number
    1625685-2020-00024
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 11, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    KADLEC ULTRASOUND DEPARTMENT HAS SUBMITTED TWO PRODUCT CONCERNS FOR THE FOLLOWING TRAYS: TRAY CATH THORA/ PARA 5FR AND TRAY PARACENTESIS THORA COMBO 8FR. WHEN USING RED NEEDLE STOPPER/HOLDER THE NEEDLE HAS BEEN GOING ALL THE WAY THROUGH THE BOTTOM OF THE TRAY. SO THE DIRTY NEEDLE IS STICKING OUT THE BOTTOM. SAFETY HAZARD IF PICKING UP TRAY TO TAKE OVER TO SHARPS CONTAINER. LIDOCAINE GLASS VIALS ARE A SAFETY HAZARD TO OUR CAREGIVERS (THICK GLASS¿NEED TO ADD A FILTER STRAW AND A SPECIAL SAW TO CUT VIAL IF NOT BREAKING WITH HANDS) L#664496 AND L#152208. MAN# OTP5000 AND TPT1000SP. PROVIDED LOTS COULD NOT BE CONFIRMED BY BD SO A CUSTOMER REQUEST WAS SENT TO CONFIRM THE LOT NUMBERS AND ANY PATIENT HARM. CUSTOMER REPLY " NO HARM TO PATIENTS. OTP5000 & TPT1000SP, THESE WERE VERIFIED. TECH SAID THAT WHAT IS ON THE TRAYS SHE LOOKED AT. I WILL SEND YOU SOME PHOTOS'. ONE PHOTO PROVIDED AND ATTACHED. THE PHOTO PROVIDED COULD NOT VERIFY THE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279103 5 FR NON-VALVED THORA/PARA TRAY NEEDLE, CATHETER GCB CAREFUSION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other