BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    MDR report key: 8624404 · Received May 20, 2019

    Report

    Report Number
    3003152976-2019-00335
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1808101, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PHASEAL OPTIMA PRODUCTS ARE EVALUATED FOR THEIR ABILITY TO PERFORM INFUSIONS AND THE RESULTS WERE FOUND TO BE ACCEPTABLE. SEVERAL FACTORS CAN CONTRIBUTE TO THE DELAY IN A GRAVITY INFUSION; HEIGHT OF THE IV BAG; PATIENT POSITION, OR MOVEMENT OF THE IV ACCESS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA INJECTOR (N35-O) EXPERIENCED FLOW ISSUES DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052 BATCH NO: UNKNOWN. EVENT DESCRIPTION PER CUSTOMER'S EMAIL STATES: A PATIENT WAS RECEIVING A GRAVITY INFUSION WITH AN INJECTOR AND CONNECTOR ON THE END. THE INFUSION WAS SUPPOSED TO GO IN OVER 10 MINUTES AND IT TOOK 25 MINUTES TO INFUSE. NO PATIENT HARM JUST DELAYED THE DELIVERY OF THE MEDICATION.

    Additional Manufacturer Narrative · 1

    (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 THAT THE BD PHASEAL OPTIMA INJECTOR (N35-O) EXPERIENCED FLOW ISSUES DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052, BATCH NO: UNKNOWN. EVENT DESCRIPTION PER CUSTOMER'S EMAIL STATES: A PATIENT WAS RECEIVING A GRAVITY INFUSION WITH AN INJECTOR AND CONNECTOR ON THE END. THE INFUSION WAS SUPPOSED TO GO IN OVER 10 MINUTES AND IT TOOK 25 MINUTES TO INFUSE. NO PATIENT HARM JUST DELAYED THE DELIVERY OF THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416310 BD PHASEAL OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1808101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other