BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 15164203 · Received August 4, 2022

    Report

    Report Number
    3003152976-2022-00347
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 5, 2022
    Report Date
    January 11, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHYSICAL INJECTOR SAMPLE WAS RETURNED FOR EVALUATION. ONE PHOTO SAMPLE WAS PROVIDED WHICH SHOWS LIQUID INSIDE THE INJECTOR PISTON, NO FLUID IS OBSERVED OUTSIDE OF THE INJECTOR. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2112007, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE VISUAL INSPECTION, A PARTICLE WAS OBSERVED OVER THE PLUNGER. FIVE RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED WITHIN ANY OF THE INJECTORS. FUNCTIONAL TESTING WAS PERFORMED, IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGES OCCURRED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, NO ISSUES RELATED TO THE REPORTED EVENT WERE FOUND DURING MANUFACTURING. BASED ON THE QUALITY TEAM'S INVESTIGATION, AND GIVEN THE DEVICE RECORDS DID NOT IDENTIFY ANY ISSUES RELATED TO THIS INCIDENT, A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. IT IS LIKELY AN ISOLATED ISSUE THAT OCCURRED DUE TO THE PRESSURE GENERATED BY THE CONNECTION DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE APPEARED TO BE LEAKAGE WITHIN THE INJECTOR LUER LOCK (N35) PIECE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE APPEARED TO BE LEAKAGE WITHIN THE INJECTOR LUER LOCK (N35) PIECE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166875 BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515003 2112007 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown