BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SP

    MDR report key: 21831468 · Received April 11, 2025

    Report

    Report Number
    3002682307-2025-00047
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 27, 2025
    Report Date
    June 12, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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 306546 AND LOT NUMBER 4241906. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. CONTROLS AT THE MANUFACTURING SITE WERE REVIEWED AND FOUND TO BE ACCEPTABLE, INCLUDING BIOBURDEN TESTING DURING WEEKDAYS, OVERKILL STERILIZATION PROCESS, ENVIRONMENTAL TESTING WITHIN THE FILLING AREAS, SOLUTION FILTRATION, DAILY ENDOTOXIN TESTING, AND CONTINUOUS MONITORING OF THE WATER QUALITY. AS SAMPLES WERE NOT AVAILABLE FOR RETURN, RETAINED SAMPLES FROM THE MANUFACTURING FACILITY WERE TESTED FOR APPEARANCE AND CLARITY. THE RETAINED SAMPLES HAVE SHOWN NO SIGN OF CLARITY ISSUES IN SALINE SOLUTION. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE AND AN EXACT CAUSE COULD NOT BE DETERMINED. THE PLASTIC MATERIAL USED TO MOLD THE BARREL MAY BE LESS TRANSPARENT COMPARED TO OTHER MANUFACTURERS, SO THE SOLUTION MAY APPEAR CLOUDY. 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 SP SOLUTION IS CLOUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A REPORT FROM OUR ED THAT THEY ARE FINDING "CLOUDY" FLUSHES. NOT SURE IF THAT'S TO BE EXPECTED OR NOT BUT WE WANT TO BE SAFE. ADDITIONAL INFORMATION RECEIVED ON 30MAR2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT NO PATIENT HARM OR ADVERSE EVENTS HAVE OCCURRED. THEY OBSERVED THE DEFECT AND PULLED THE PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022499 BD POSIFLUSH SP SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 4241906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown