BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 25209589 · Received May 18, 2026

    Report

    Report Number
    1911916-2026-00228
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 18, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G.4. APPLICABLE 510K NUMBERS ARE K003553;K161552. 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

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 306547 BATCH#: UNKNOWN VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED BD #306547: BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE, 10 ML SYRINGE 10 ML SALINE FILL OUR TEAM IS INDICATING THERE IS A LIP ON THE FLANGE OF THE SYRINGE CAUSING THE MEDFUSION PUMPS TO ALERT WITH A MESSAGE OF "OCCLUSION." HAS SOMETHING CHANGED WITH THESE? THE REGULAR SYRINGES DON'T HAVE THIS LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179823 BD POSIFLUSH SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1