BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORA-PARA 5 FRENCH NON-VALVED CATHETER DRAINAGE TRAY

    MDR report key: 13076401 · Received December 23, 2021

    Report

    Report Number
    13076401
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    December 18, 2021
    Report Date
    December 20, 2021
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    PXI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ADULT MALE ADMITTED WITH HEPATIC ENCEPHALOPATHY. HE HAS A PARACENTESIS EVERY 7-10 DAYS AS AN OUTPATIENT. AVERAGE REMOVAL IS 15L. PATIENT WAS ADMITTED WITH ALTERED LEVEL OF CONSCIOUSNESS (ALOC) AND ELEVATED AMMONIO LEVELS. THE NEXT DAY, AMMONIA LEVEL IMPROVED AND PHYSICIAN CONSENTED FOR A BEDSIDE PARACENTESIS. PLAN WAS TO PROVIDE RELIEF UNTIL THE REMAINDER COULD BE REMOVED ON HIS REGULAR DAY. PROVIDER STARTED THE PROCEDURE AND DRAINED FIRST TWO LITERS EASILY. THE THIRD LITER BEGAN TO SLOW DOWN AND FINALLY STOPPED. A TOTAL OF 300ML HAD BEEN REMOVED AT THAT TIME. THE REASON FOR THE SLOW TO A STOP OF DRAINAGE WAS UNCLEAR. PROVIDER DETERMINED THAT ENOUGH HAD BEEN REMOVED. PHYSICIAN BEGAN TO REMOVE THE YEUH CATHETER BY PULLING BACK ON THE DEVICE AND THEN HE ANNOUNCED THAT THE YEUH CATHETER HAD SEPARATED FROM THE THREE WAY WHILE RETRACTING IT. THE YEUH CATHETER RECEDED INTO THE PATIENT AND PHYSICIAN WAS UNABLE TO RETRIEVE IT. AN ULTRASOUND AND CT OF ABDOMEN WERE ORDERED AND FOUND THAT THE YUEH CATHETER WAS IN THE RIGHT LATERAL ASPECT OF THE ABDOMINAL REGION AND CONSISTENT WITH A FOREIGN BODY. THE NEXT DAY, PATIENT WENT INTO SURGERY FOR A LAPAROSCOPIC RETRIEVAL OF THE FOREIGN BODY FROM THE PERITONEAL CAVITY. SET USED: THORA-PARA 5 FRENCH NON-VALVED CATHETER DRAINAGE TRAY; LOT: # 0001437013; EXPIRATION: DATE 2022-10-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976462 THORA-PARA 5 FRENCH NON-VALVED CATHETER DRAINAGE TRAY THORACENTESIS TRAY PXI CAREFUSION 2200, INC. OTP5000

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Male Required Intervention| O