BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH

    MDR report key: 23459867 · Received November 3, 2025

    Report

    Report Number
    1911916-2025-00715
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. THIS COMPLAINT WAS FOUND TO BE A DUPLICATE AFTER THE MDR WAS SUBMITTED, PLEASE REFER TO MDR 13312419.

    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

    (B)(4) IS A DUPLICATE COMPLAINT AND WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML REG PR SALINE 10ML FILL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 306546. BATCH#: 5111174. VERBATIM: RCC RECEIVED A COMPLAINT VIA WEB. PIR ATTACHED. WE OBSERVED VISIBLE PARTICULATES AFTER EXPRESSING A BD POSIFLUSH 0.9% SODIUM CHLORIDE INJECTION, USP, 10 ML SYRINGE FROM LOT 5111174 INTO A SINK. FACILITY PRODUCT DETAILS: LOT: 5111174 / EXP: 2028-03-31. REF: (B)(4). QUANTITY ON HAND: APPROXIMATELY 14 CASES (ALL QUARANTINED). FIRST OBSERVED: 2025-10-08, AFTERNOON. NO PATIENT WAS INJECTED; OCCURRENCE IDENTIFIED DURING PREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219671 POSIFLUSH PERIPHERAL IV CATHETERS FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 5111174 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown