BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 12640484 · Received October 15, 2021

    Report

    Report Number
    3003152976-2021-00693
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 13, 2021
    Report Date
    December 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150524
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2102316, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED AND LEAKAGE TEST PERFORMED, NO DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR ALONG WITH A SAMPLE SYRINGE AND MATING COMPONENTS TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED BD PHASEAL OPTIMA INJECTOR (N35-O) HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAD A LEAKING INJECTOR( N35-O) REPORTED TO US BY THE CHEMO SUITE.".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDITIONAL PHONE#:(B)(6). 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 BD PHASEAL OPTIMA INJECTOR (N35-O) HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAD A LEAKING INJECTOR( N35-O) REPORTED TO US BY THE CHEMO SUITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539665 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2102316 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown