BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS/SF

    MDR report key: 22410762 · Received July 7, 2025

    Report

    Report Number
    9616657-2025-00012
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 13, 2025
    Report Date
    September 9, 2025
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES AND ONE (1) PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, DAMAGE WAS OBSERVED ON THE TOP WEB OF THE PACKAGING. A REVIEW OF MES (MANUFACTURING ENGINEERING SYSTEM) WITH THE TECHNICAL TEAM SHOWED THAT THERE HAD BEEN AN ISSUE ON THE PACKAGING ROBOT ON A SHIFT DURING THE MANUFACTURE OF THIS BATCH, WHICH IS THE MOST LIKELY ROOT CAUSE OF THIS ISSUE. THE ISSUE WAS CONFIRMED RESOLVED ON THE NEXT SHIFT. 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 BD POSIFLUSH-XS / SF UNIT PACKAGE IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT DETAILS: DAMAGED PACKAGING PATIENT IMPACT: NO HARM CAUSED TO A PATIENT USED/UNUSED? NOT OPENED AND NOT SENT TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2818666 BD POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4242754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown