BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLOSED SYSTEM TRANSFER DEVICE PHASEAL PROTECTOR

    MDR report key: 22531940 · Received July 17, 2025

    Report

    Report Number
    MW5172855
    Event Type
    Other
    Date Received
    July 17, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM THE (B)(6) PHARMACY. THE PHASEAL OPTIMA VIAL PROTECTOR DID NOT INFLATE; AIR COULD NOT BE ADDED TO THE VIAL. WE HAD IT HAPPEN TWICE ¿ ONCE WAS ON (B)(6) WITH A KADCYLA. IT WOULD NOT ALLOW DILUENT IN FOR RECONSTITUTION. THE SECOND WAS A CISPLATIN THAT WOULDN'T ALLOW AIR IN. WE DIDN'T TRY TO PULL BACK AGAINST THE NEGATIVE PRESSURE. PATIENT CODE: 4582. DEVICE CODES: 2991; 2588; 2338. REFERENCE REPORT: MW5172856.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839493 CLOSED SYSTEM TRANSFER DEVICE PHASEAL PROTECTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CISPLATIN.| KADCYLA.