BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SYRINGE

    MDR report key: 18230461 · Received November 29, 2023

    Report

    Report Number
    9616657-2023-00053
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 2, 2023
    Report Date
    March 6, 2024
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 3172390. THE REVIEW DID NOT IDENTIFY ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOUR (4) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ANALYSIS OF THE PHOTOGRAPHS CONFIRM THE PRESENCE OF FOREIGN MATTER; HOWEVER, WITHOUT THE PHYSICAL SAMPLE WE ARE UNABLE TO DETERMINE THE TYPE OF FOREIGN MATTER AND ALSO CONFIRM IF THE FOREIGN MATTER IS IN THE SALINE SOLUTION. IF A PHYSICAL SAMPLE BECOMES AVAILABLE, ADDITIONAL INVESTIGATION RESULTS MAY BE POSSIBLE. 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 DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH SYRINGE HAS FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE OPENED THE SYRINGE FROM THE CLEAR PACKAGING AND NOTICED THE FLOATING PARTICLE IN THE SYRINGE. NURSE BROUGHT THE SYRINGE TO MYSELF, AS I WAS IN HER DEPARTMENT AT THE TIME. NO PATIENT HARM IN THIS INCIDENT, JUST A QUALITY ISSUE. NO IMPACT, AS THE PROBLEM WAS DISCOVERED BEFORE A PATIENT WOULD HAVE BEEN IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98128 BD POSIFLUSH SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 3172390 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown