BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)

    MDR report key: 8636074 · Received May 23, 2019

    Report

    Report Number
    3003152976-2019-00341
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 12, 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

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1807721, 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) WAS HAVING FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515070; BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS SUPPOSED TO GO IN OVER 10 MINUTES AND IT TOOK 25 MINUTES TO INFUSE. EVENT DESCRIPTION STATES, YESTERDAY A PATIENT WAS RECEIVING A GRAVITY INFUSION WITH AN OPTIMA 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) WAS HAVING FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515070, BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS SUPPOSED TO GO IN OVER 10 MINUTES AND IT TOOK 25 MINUTES TO INFUSE. EVENT DESCRIPTION STATES, YESTERDAY A PATIENT WAS RECEIVING A GRAVITY INFUSION WITH AN OPTIMA 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
    428253 BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1807721

    Patients

    Seq Age Sex Outcome Treatment
    1 Other