BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 8911727 · Received August 20, 2019

    Report

    Report Number
    3003152976-2019-00566
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 10, 2019
    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

    H.6. INVESTIGATION SUMMARY: TWO SAMPLES INDICATED TO BE CONTAMINATED WITH HAZARDOUS MEDICATION WERE RETURNED TO OUR QUALITY ENGINEER. DUE TO SAFETY REGULATIONS, WE CANNOT HANDLE CHEMO CONTAMINATED ITEMS AND THE RETURNED PRODUCT COULD NOT BE EVALUATED. THREE RETAINED SAMPLES OF THE LOT 1904110 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR TO A SAMPLE SYRINGE, PROTECTOR AND VIAL ACCORDING TO THE INSTRUCTIONS FOR USE. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. SAMPLE WERE THEN DISASSEMBLED AND CONNECTED TO A SAMPLE CONNECTOR. THE INJECTOR WAS ENGAGED AND DISENGAGED FIVE TIMES WITHOUT ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1904110, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. CONCLUSION: BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. THE INSTRUCTIONS FOR USE MUST BE CAREFULLY FOLLOWED WHEN USING THE PHASEAL DEVICES TO ENSURE THE PRODUCT FUNCTIONS AS INTENDED. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. CAPA 708467 WAS OPENED TO INVESTIGATE THIS KIND OF DEFECT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35 WOULDN'T LUER LOCK / ENGAGE TO THE CONNECTOR DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD ONE ISSUE WITH ONE INJECTOR, IT WOULDN¿T LUER LOCK, IT LINED UP OK BUT WE COULDN¿T GET IT TO CONNECT, IT WOULDN¿T ENGAGE, IT FLATTENED BUT THEN WE COULDN¿T GO ANY FURTHER. FIRST STEP WE CHANGED THE CONNECTOR TO SEE IF THAT MADE A DIFFERENCE, WHEN IT DIDN¿T, WE CHANGED THE INJECTOR AND IT LUER LOCKED OK AND WE WERE ABLE TO ENGAGE. THIS WAS FOR AND IV PUSH. I¿M ASSUMING THEY ARE ALL THE SAME LOT # SO LIKELY A ONE-OFF BUT WILL MONITOR TO SEE IF IT HAPPENS AGAIN." "THREE DIFFERENT PEOPLE ATTEMPTED, MYSELF INCLUDED. ALL RIGHT HANDED AND I¿M CONFIDENT WE WERE DOING IT CORRECTLY AS WHEN WE CHANGED THE INJECTOR, WE HAD NO ISSUES."

    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 THE BD PHASEAL¿ INJECTOR LUER LOCK N35 WOULDN'T LUER LOCK / ENGAGE TO THE CONNECTOR DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD ONE ISSUE WITH ONE INJECTOR, IT WOULDN¿T LUER LOCK, IT LINED UP OK BUT WE COULDN¿T GET IT TO CONNECT, IT WOULDN¿T ENGAGE, IT FLATTENED BUT THEN WE COULDN¿T GO ANY FURTHER. FIRST STEP WE CHANGED THE CONNECTOR TO SEE IF THAT MADE A DIFFERENCE, WHEN IT DIDN¿T, WE CHANGED THE INJECTOR AND IT LUER LOCKED OK AND WE WERE ABLE TO ENGAGE. THIS WAS FOR AND IV PUSH. I¿M ASSUMING THEY ARE ALL THE SAME LOT # SO LIKELY A ONE-OFF BUT WILL MONITOR TO SEE IF IT HAPPENS AGAIN." "THREE DIFFERENT PEOPLE ATTEMPTED, MYSELF INCLUDED. ALL RIGHT HANDED AND I¿M CONFIDENT WE WERE DOING IT CORRECTLY AS WHEN WE CHANGED THE INJECTOR, WE HAD NO ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707361 BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1904110 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other