BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH XS/SF

    MDR report key: 24291145 · Received February 9, 2026

    Report

    Report Number
    9616657-2026-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 11, 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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    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 POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE AND ONE (1) PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE DEFECT OF PACKAGE DAMAGE, TEAR IN THE WEB, WAS OBSERVED. A REVIEW OF THE MANUFACTURING ENGINEERING SYSTEM (MES) SHOWED NO ISSUES AT THE MULTIVAC DURING THE MANUFACTURING OF THE LOT. HOWEVER, THERE WERE ENTRIES RELATING TO THE PACKAGING STATION AT THE LINE. BASED ON THE PHYSICAL SAMPLE AND THE ENTRIES ON MES, THE MOST PROBABLE ROOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRIMARY PACKAGE OF A STERILE PRODUCT IS DAMAGED. X1 SYRINGE PACKAGE, DAMAGED DUE TO BOX PRESSURE. INCIDENT DATE: (B)(6) 2026. NO HARM CAUSED TO A PATIENT ¿ NOT OPENED AND NOT SENT TO CUSTOMER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608098 POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4242754 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown