BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 24652671 · Received March 20, 2026

    Report

    Report Number
    3002682307-2026-00026
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. APPLICABLE 510K NUMBERS ARE K003553;K141311;K250884 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 BD SYRINGE 10ML REG PR SALINE 10ML FILL HAD DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306546 BATCH # 5295643, 5288002 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER STATES THEY FOUND SOME 10ML BD FLUSH SYRINGES THAT APPEAR CLOUDY. UNKNOWN TOTAL NUMBER OF QUANTITY. MORE THAN 1 FOR SURE. ADDITIONAL INFORMATION PROVIDED: PLEASE CLARIFY WHAT IS CLOUDY. - THE SALINE SOLUTION? YES? - THE SYRINGE/MOLDED PARTS? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20334 BD POSIFLUSH SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 5295643 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown