BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS

    MDR report key: 12680990 · Received October 22, 2021

    Report

    Report Number
    12680990
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 12, 2021
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    PXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLINICAL STAFF PULLED A SAFE-T-CENTESIS 6 FR CATHETER DRAINAGE TRAY TO PREPARE FOR A PATIENT. UPON OPENING THE TRAY, THE HEALTH CARE PROVIDERS DISCOVERED THAT ONE OF THE ENCLOSED ITEMS WAS DAMAGED. THE ISSUE IS THAT THE CENTESIS CATHETER DRAINAGE DEVICE FROM THE KIT/TRAY WAS BENT. DAMAGED ITEMS WERE THEN DISCARDED AND A NEW TRAY WAS PULLED. THIS INCIDENT OCCURRED THREE MORE TIMES WITH TRAYS, ALL FROM THE SAME LOT NUMBER. NO DEFECTIVE PRODUCT WAS USED ON A PATIENT. ALL THE DEFECTIVE/FAULTY PRODUCTS WERE DISCARDED. OUR ENDO PRE/POST DEPARTMENT HAS REPORTED AN ISSUE WITH FOUR OF ONE ITEM. ALL FOUR ITEMS WERE OF THE SAME LOT #. THE ISSUE IS THAT THE CENTESIS CATHETER DRAINAGE DEVICE FROM THE KIT/TRAY THE NEEDLE WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582517 SAFE-T-CENTESIS THORACENTESIS TRAY PXI CAREFUSION 2200, INC PIG1260T 0001425282

    Patients

    Seq Age Sex Outcome Treatment
    1