BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS

    MDR report key: 19642802 · Received July 1, 2024

    Report

    Report Number
    19642802
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 4, 2024
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    PXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "SITUATION: SAFE-T-CENTESIS NEEDLE FOUND TO BECOME STUCK IN THE "SHARP" POSITION BACKGROUND: THE SAFE-T-CENTESIS NEEDLE IS DESIGNED TO BECOME SHARP WHEN PRESSING AGAINST SOLID TISSUE THEN TO RETRACT TO BLUNT WHEN IN FREE SPACE DECREASING RISK OF PUNCTURING NEARBY ORGAN. ASSESSMENT: THE DEVICE IS DEFECTIVE. RECOMMENDATION: WOULD LIKE TO SEE IF THIS IS A "ONE OFF" OR IF OTHER DEFECTIVE DEVICES HAVE BEEN IDENTIFIED POINTING TO LARGER ISSUE WITH THE DEVICE ITSELF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174970 SAFE-T-CENTESIS THORACENTESIS TRAY PXI CAREFUSION 2200, INC PIG1280K 000159909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown