BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHENA

    MDR report key: 24131972 · Received January 21, 2026

    Report

    Report Number
    2243072-2026-00024
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 5, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868612
    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 VIDEO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF NEEDLE DISENGAGEMENT DIFFICULT WAS CONFIRMED UPON INSPECTION OF THE VIDEO. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY THE CUSTOMER 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 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. I HAVE ATTACHED A VIDEO OF THE EVENT. IT ONLY REQUIRES MODERATE PRESSURE TO DISENGAGED WHILE STARTING THE IV ESPECIALLY FOR THE SMALLER GAUGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192448 CATHENA Catheter, intravascular, therapeutic, short-term less than 30 days FOZ BECTON DICKINSON 5096085 00382903868612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown