BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS/SF

    MDR report key: 22071748 · Received May 22, 2025

    Report

    Report Number
    9616657-2025-00007
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 22, 2025
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS THE RESULT OF AN INVESTIGATION FINDING: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 4242754. THE REVIEW DID NOT REVEAL ANY POSSIBLE DETECTED PRODUCT NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE BEEN RELATED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, PACKAGE DAMAGE ON THE TOP WEB COMPONENT WAS OBSERVED. THIS PACKAGE DAMAGE WOULD BREACH THE STERILITY OF THE BLISTER PACK. A REVIEW OF THE MES (MANUFACTURING ENGINEERING SYSTEM) WITH THE TECHNICAL TEAM SHOWED THAT THERE HAD BEEN AN ISSUE WITH THE PACKAGING ROBOT ON A SHIFT DURING THE MANUFACTURE OF THIS BATCH WHICH MOST LIKELY CAUSED DAMAGE TO THE PACKAGING TOP WEB. THIS ISSUE WAS CONFIRMED RESOLVED ON THE NEXT SHIFT. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF DEFECT ON LOT NUMBER 4242754. 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 BD POSIFLUSH-XS / SF HAD PACKAGE DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSIFLUSH OUTER PACKAGE (PAPER SIDE) DAMAGE DUE THE PRESSURE COMPACTED INSIDE BOX AND POSITION OF THE SYRINGE FROM SUPPLIER. FOUND IN PPA AREA NO HARM CAUSED TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367153 BD POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4242754 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown