BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURX DRAINAGE KIT 50-7510

    MDR report key: 8803208 · Received July 17, 2019

    Report

    Report Number
    MW5088219
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 15, 2019
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    DWM
    UDI-DI
    50885403090705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE A CAREFUSION 50-7510 PLEURX DRAINAGE SYSTEM TO REMOVE FLUID FROM MY MESOTHELIOMA-INFECTED RIGHT LUNG. ON JULY 12, WE HAD JUST INSERTED THE PLEURX VACUUM BOTTLE ACCESS TIP INTO MY CHEST CATHETER WHEN THE CONNECTION BETWEEN THE CATHETER AND THE PLEURX BOTTLE (THE "ACCESS TIP") BEGAN TO LEAK. WE QUICKLY DISCONNECTED THE BOTTLE AND CONNECTED A FRESH ONE. THAT STOPPED THE LEAK. INSPECTION OF THE FAILED ACCESS TIP REVEALED A PROBABLE MFG DEFECT. THE SMALL TUBE THAT GETS INSERTED INTO MY CHEST CATHETER HAD AN OBLONG OPENING IN THE TUBE. THAT DEFECT PERMITTED MY PLEURAL FLUID TO LEAK OUT ONTO MY CLOTHING AND AIR TO ENTER THE CATHETER / VACUUM BOTTLE TUBING. I AM CONCERNED THAT I MIGHT HAVE BEEN AT RISK FROM AN EMBOLISM CAUSED BY THE PLEURX DEVICE. I AM ATTACHING PICTURES OF BOTH THE DEFECTIVE "ACCESS TIP" AND THE PLEURX 50-7510 DRAINAGE KIT (LOT 0001274435) SO THAT THIS SCARY EVENT MAY BE PROPERLY INVESTIGATED. AIR LEAK - PLEURAL CATHETER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594876 PLEURX DRAINAGE KIT 50-7510 APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 2200, INC. 50-7510 0001274435 50885403090705

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other