BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 23949268 · Received January 2, 2026

    Report

    Report Number
    1911916-2025-00824
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. A BLACK PARTICULATE RESEMBLING AN INSECT WAS REPORTEDLY OBSERVED FLOATING IN THE SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT FLOW WRAP PACKAGING WAS RECEIVED FOR EVALUATION BY THE QUALITY TEAM. THE SYRINGE CONTAINED 3.5ML OF SOLUTION, AND THE PLUNGERS RUBBER STOPPER WAS POSITIONED AT THE 8ML GRADUATION MARK. A VISUAL INSPECTION IDENTIFIED NO FOREIGN MATTER. THE SOLUTION WAS SUBSEQUENTLY TRANSFERRED TO A GLASS CONTAINER, WHERE NO FOREIGN MATTER WAS OBSERVED UPON RE INSPECTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306547, LOT 5212358. THE REVIEW REVEALED NO DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING THE ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMERS REPORTED CONDITION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO HARM HAS COME TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL CONTAINED FOREIGN MATTER. VERBATIM: PATIENT STATES THERE IS SOMETHING BLACK FLOATING IN THE SYRINGE THAT LOOKS LIKE A BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4047 BD POSIFLUSH SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 5212358 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other