BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURAL CATHETER SYSTEM

    MDR report key: 15249584 · Received August 17, 2022

    Report

    Report Number
    MW5111553
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    August 12, 2022
    Report Date
    August 15, 2022
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN INCIDENT THAT HAPPENED AROUND 5 PM, AFTER SURGERY REGARDING A PATIENT. THE FELLOW CAME TO THE SURGERY FRONT DESK AND INFORMED OF AN INCIDENT. PATIENT HAD A TENSION PNEUMO FOLLOWING HIS VIDEO ASSISTED THORACOTOMY WITH A PLEURAX PLACEMENT. A WHITE CONNECTOR PIECE FROM THE KIT WAS NOT PATENT. HE WAS TROUBLE SHOOTING THE SYSTEM AT THE PATIENT'S BEDSIDE OF WHY THE CATHETER WAS NOT WORKING PROPERLY. WHEN HE DISASSEMBLE THE SETUP, HE NOTICED THE PIECE FROM THE KIT WAS NOT PATENT. THIS PIECE WAS IMMEDIATELY REMOVED AND CHANGED AND THEN THE CATHETER WAS WORKING PROPERLY. THE FELLOW BROUGHT THE CONNECTOR BACK TO THE OPERATING ROOM FOR THE SURGICAL SERVICES TO FOLLOW UP. I CALLED SICU TO CHECK ON THE PATIENT HE WAS STABLE AND DOING WELL. THE LOT NUMBER OF THE INSERTED CATHETER IS 0001471891 WE HAD 2 IN THE SURGICAL UNIT THAT WERE PULLED, AND MATERIALS MANAGEMENT WAS NOTIFIED OF THE LOT NUMBER TO PULL AND RETAIN ALL UNITS TO SWAP OUT FOR DIFFERENT KITS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493356 PLEURAL CATHETER SYSTEM APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 2200, INC. 0001471891

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention