BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH XS/SF

    MDR report key: 23903462 · Received December 28, 2025

    Report

    Report Number
    9616657-2025-00025
    Event Type
    Malfunction
    Date Received
    December 28, 2025
    Date of Event
    October 27, 2025
    Report Date
    February 12, 2026
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    K231161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 4242754. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCE'S THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOUR (4) PICTURE SAMPLES AND FOUR (4) PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE DEFECT OF PACKAGE DAMAGE, SPECIFICALLY TEARING IN THE TOP WEB, WAS OBSERVED. A REVIEW OF MES (MANUFACTURING ENGINEERING SYSTEM) SHOWED NO ISSUES AT THE MULTIVAC DURING THE MANUFACTURING OF THE BATCH. HOWEVER, THERE WERE ENTRIES RELATING TO THE PACKAGING STATION AT THE LINE. BASED ON THE PHOTOGRAPH PROVIDED BY THE CUSTOMER, THE CUSTOMER VERBATIM AND THE ENTRIES ON MES, THE MOST PROBABLE CAUSE WAS DAMAGE TO THE SHELF CARTON DURING PACKING INTO THE SHIPPER, WHICH IN TURN RESULTED IN THE BLISTER PACKS BEING DAMAGED. AT THIS TIME, 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

    H.3. 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

    IT WAS REPORTED THAT 2X SYRINGES - DAMAGE TO THE OUTER PACKAGING DUE TO THE FLANGE ON THE PRODUCT PROTRUDING THROUGH; FOUND DURING THE UNPACKING OF BOXES FROM THE SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324230 POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4242754 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown