BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH XS/SF

    MDR report key: 23195954 · Received October 1, 2025

    Report

    Report Number
    9616657-2025-00019
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, AN UNDERFILLED BARREL WAS OBSERVED. UNFORTUNATELY, IN ORDER TO FULLY INVESTIGATE THIS ISSUE, THE PHYSICAL SAMPLE WOULD BE NEEDED TO IDENTIFY A POSSIBLE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 4250496. THE REVIEW DID NOT REVEAL ANY DETECTED NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. THIS IS THE FIRST REPORT FOR FLUSH SYRINGE INCORRECT FILL ON MATERIAL NUMBER 306572 AND LOT NUMBER 4250496. AT THIS TIME, A CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    PRE-FILLED SYRINGE OF NACL 0.9% 10ML STERILE BD. ONE OF THE TWO PRE-FILLED SYRINGES IS ALMOST EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319459 POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4250496

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown