BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHENA

    MDR report key: 23974666 · Received January 6, 2026

    Report

    Report Number
    2243072-2026-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 14, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868032
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE VIDEOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF SAFETY MECHANISM FAILURE AND THREADING DIFFICULT WERE NOT CONFIRMED UPON INSPECTION OF THE VIDEOS. FROM VIDEO ANALYSIS IT WAS OBSERVED THAT THE USER APPLIED MANUAL FORCE TO THE SAFETY MECHANISM, INSTEAD OF ALLOWING THE PASSIVE SAFETY FEATURE TO ENGAGE AUTOMATICALLY. THE USER HELD THE NEEDLE HUB WITH SIGNIFICANT FORCE AND MANUALLY BENT THE NEEDLE, WHICH PLACED ABNORMAL STRESS ON THE MECHANISM. THIS RESULTED IN MECHANICAL MALFUNCTION AND POTENTIAL EXPOSURE TO SHARP COMPONENTS. IT IS THEREFORE RECOMMENDED TO FOLLOW THE INSTRUCTIONS FOR USE (IFU) ACCORDINGLY TO REMOVE THE CATHETER UNIT FROM NEEDLE SAFETY SHIELD AFTER INSERTION TO PREVENT NEEDLE RETRACTION/SAFETY ACTIVATION FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY MECHANISM FAILED. IT WAS REPORTED BY THE CUSTOMER THAT ABLE TO DISENGAGE THE SAFETY WHILE STARTING THE IV. WHEN HE ADDS IMMENSE PRESSURE TO THE CATHETER HUB, THE SAFETY MAKES AN AUDIBLE CLICK SOUND, AND THE SAFETY IS DEACTIVATED. WHEN HE THREADS THE CATHETER THE GRAY SAFETY MECHANISM STAYS INSIDE THE CLEAR CANNULA. WHEN HE PULLS BACK ON THE NEEDLE UPON THREADING, THE NEEDLE IS EXPOSED. VERBATIM: NURSE WAS ABLE TO DISENGAGE THE SAFETY WHILE STARTING THE IV. WHEN HE ADDS IMMENSE PRESSURE TO THE CATHETER HUB, THE SAFETY MAKES AN AUDIBLE CLICK SOUND, AND THE SAFETY IS DEACTIVATED. WHEN HE THREADS THE CATHETER THE GRAY SAFETY MECHANISM STAYS INSIDE THE CLEAR CANNULA. WHEN HE PULLS BACK ON THE NEEDLE UPON THREADING, THE NEEDLE IS EXPOSED. ADDITIONAL INFO RECEIVED ON 30-DEC: LOT # 5081570, LOT # 5096085. ONE NURSE WAS INJURED FROM A NEEDLE STICK AFTER PLACING AN IV. THEY BELIEVED THAT THE SAFETY HAD ACTIVATED BUT WHEN THEY WENT TO PUT THROW AWAY THE SHARP THEY WERE POKED. A NURSE ON A DIFFERENT FLOOR PLACED AN IV AND STATED THAT THE SAFETY DID NOT ENGAGE, THEY NOTICED THE ISSUE AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558091 CATHENA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5081570 00382903868032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown