BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED SYSTEM TRANSFER DEVICE PHASEAL PROTECTOR

    MDR report key: 22535320 · Received July 17, 2025

    Report

    Report Number
    MW5172893
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAD PHASEAL MALFUNCTION TODAY. WHILE BEGINNING TO MIX A GEMCITABINE, THE TUBING FELL OUT OF THE NSS 250 BAG. THE TECHNICIAN HAD LIFTED THE BAG TO TAKE OUT THE NSS TO RECONSTITUTE THE GEMCITABINE, AND THE SPIKE FELL OUT OF THE BAG. THIS OCCURRED AT THE (B)(6). FK NSS 250 ML LOT:6402420 EXP: 3/2028, BD ALARIS PUMP INFUSION SET (10015861A), LOT: (10)25035363 EXP: 3/13/28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2752065 CLOSED SYSTEM TRANSFER DEVICE PHASEAL PROTECTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON 2502409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown