BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA

    MDR report key: 25166852 · Received May 14, 2026

    Report

    Report Number
    3003152976-2026-00229
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 4, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 THE BD PROTECTOR P53J HAD A LEAK BETWEEN THE PROTECTOR AND VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT LIQUID LEAKED FROM GAPS IN THE VIALS, LEAKAGE OCCURRED WHILE PREPARING KILOCIDE DURING USE. CUSTOMER IS SENDING TWO VIALS, BUT HE COULD NOT REMEMBER IF THE LEAK OCCURRED FROM ONE OF THEM. WE WILL ALSO SEND THE INJECTOR USED IN THE PREPARATION TOGETHER. TEAM LEADER RESPONSE: Q:DO YOU ASSEMBLE THE PROTECTORS BY HAND OR USING AN ASSEMBLY JIG? A:MANUAL WORK Q:IS THE PROTECTOR STUCK IN THE CENTER OF THE STOPPER OF THE VIAL? A:UNKNOWN Q:WAS THE PROTECTOR COMPLETELY ASSEMBLED? A:HE SAID IT WAS A LITTLE WOBBLY. Q: IS LOT INFORMATION AVAILABLE? A:UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611593 BD PHASEAL OPTIMA CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown