BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 12580852 · Received October 6, 2021

    Report

    Report Number
    3003152976-2021-00661
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    August 25, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    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

    H.6. INVESTIGATION: 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, SAMPLE WAS ATTACHED TO A SYRINGE+ A PROTECTOR CONNECTED TO A VIAL. AFTER ASPIRATING THE COLORANT FROM THE VIAL TO THE SYRINGE, NO ISSUES OR LEAKAGE WERE FOUND ON THE INJECTOR. NO LUER LOCK DISCONNECTION OCCURRED. 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. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, 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 THE BD PHASEAL OPTIMA INJECTOR (N35-O) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING. IT IS EITHER COMING FROM THE CONNECTION POINT BETWEEN THE NEEDLE AND THE CONNECTOR OR THE CONNECTOR AND THE INJECTOR. I WOULD SAY THAT IT IS MORE PROBABLE BETWEEN THE NEEDLE AND CONNECTOR.

    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 OPTIMA INJECTOR (N35-O) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING. IT IS EITHER COMING FROM THE CONNECTION POINT BETWEEN THE NEEDLE AND THE CONNECTOR OR THE CONNECTOR AND THE INJECTOR. I WOULD SAY THAT IT IS MORE PROBABLE BETWEEN THE NEEDLE AND CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478738 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. 2102316 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown