BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 9371620 · Received November 25, 2019

    Report

    Report Number
    3003152976-2019-00807
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 7, 2019
    Report Date
    January 6, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K140591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTO, THE INJECTOR NEEDLE IS OBSERVED TO BE EXPOSED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1902105, NO DEVIATIONS OR NON-CONFORMANCE'S WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS IDENTIFIED. TESTING WAS COMPLETED, ATTACHING THE INJECTOR TO A SYRINGE AND ENGAGING WITH A PROTECTOR CONNECTED TO A VIAL. AFTER DRAWING LIQUID, THE INJECTOR WAS DISENGAGED AND THEN ENGAGED WITH A SAMPLE CONNECTOR. THIS PROCESS WAS REPEATED THREE TIMES ON ALL RETAINED SAMPLE INJECTORS. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED, THE NEEDLE DID NOT BECOME EXPOSED, AND THE FAILURE COULD NOT BE REPLICATED. BASED UPON THE QUALITY TEAMS INVESTIGATION AND SINCE NO INCIDENT HAS BEEN FOUND DURING THE MANUFACTURING PROCESS RELATED TO THIS DEFECT, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BREAKAGE OCCURRED DURING USE WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, " JUST WANTED TO LET YOU KNOW THAT WE HAD AN ISSUE WITH THE PHASEAL INJECTOR ON THE WEEKEND. WHEN THE INJECTOR WAS REMOVED FROM THE CONNECTOR, THE NEEDLE REMAINED EXPOSED. WE'VE COMPLETED AN OCCURRENCE REPORT BUT I WAS TOLD IT HAPPENED 3-4 TIMES ON THE WEEKEND." 4 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BREAKAGE OCCURRED DURING USE WITH A BD PHASEAL¿ INJECTOR LUER LOCK N35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, " JUST WANTED TO LET YOU KNOW THAT WE HAD AN ISSUE WITH THE PHASEAL INJECTOR ON THE WEEKEND. WHEN THE INJECTOR WAS REMOVED FROM THE CONNECTOR, THE NEEDLE REMAINED EXPOSED. WE'VE COMPLETED AN OCCURRENCE REPORT BUT I WAS TOLD IT HAPPENED 3-4 TIMES ON THE WEEKEND." 4 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168026 BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902105 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other