BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH

    MDR report key: 25243291 · Received May 21, 2026

    Report

    Report Number
    1911916-2026-00230
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. G.4. ADDITIONAL 510K: K003553.

    Description of Event or Problem · 0

    IT IS REPORTED, SYR 10ML PUMP COMPATIBLE SALINE 10ML, PLUNGERS ARE ¿STICKY¿/HIGHER FRICTION, NOT ALLOWING TO INFUSE MEDICATIONS VIA THE SYRINGE PUMPS. ADDITIONAL INFORMATION THE PATIENT WAS RECEIVING A MEDICATION (MADE BY NURSING) VIA IV SYRINGE. WE MADE THE MEDICATION USING THE SALINE FLUSH SYRINGES. THERE WAS 10ML OF VOLUME, ONLY 4ML WENT IN AND THE PUMP BEGAN TO ALARM CONSISTENTLY. WE TRIED RESECURING DIFFERENT CONNECTIONS, BUT THIS DID NOT WORK. WE HAD TO CHANGE THE SYRINGE TO A REGULAR, EMPTY 10ML SYRINGE, AND ONLY AT THIS CHANGE DID THE PUMP WORK AGAIN. IF SYRINGES CONTINUE TO BE MALFUNCTIONING, MEDICATIONS WILL NOT BE ADMINISTERED IN A TIMELY MANNER AND OTHER MEDS/PATIENT CARE BECOME DELAYED. ON TOP OF THIS, PATIENTS WILL NOT RECEIVE THEIR MEDICATIONS EFFICIENTLY, THEREFORE PROLONGING ANY SYMPTOMS/ILLNESS. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432083 POSIFLUSH SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 5295412 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1