BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL

    MDR report key: 25130849 · Received May 8, 2026

    Report

    Report Number
    3003152976-2026-00222
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 4, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150050
    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 INJECTOR LUER LOCK N35C MULTIPACK HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT LEAKING FROM INJECTOR MEMBRANE DURING USE. ADDITIONAL INFORMATION PROVIDED: TEAM LEADER RESPONSE: 1) Q: IS ANY LEAKAGE OBSERVED WHILE THE INJECTOR IS CONNECTED TO THE CONNECTOR? A:NO, HE SAID THERE WAS NOT. Q: AFTER THE MEMBRANE IS REMOVED, IS THERE ANY EVIDENCE OF LIQUID ON THE MEMBRANE? A: YES, THERE WAS. Q: IS IT POSSIBLE TO PROVIDE PHOTOGRAPHS? A: WE HAVE ALREADY SENT THEM TO KONOIKE MEDICAL. Q:IS IT POSSIBLE TO OBTAIN LOT INFORMATION? A: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306352 BD PHASEAL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB BECTON DICKINSON, S.A. UNKNOWN 00382905150050

    Patients

    Seq Age Sex Outcome Treatment
    1