BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR C35-O

    MDR report key: 12422577 · Received September 3, 2021

    Report

    Report Number
    3003152976-2021-00556
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    July 24, 2021
    Report Date
    September 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2102506, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. SEVEN RETAINED SAMPLES OF THE SAME LOT 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 CONNECTOR ACCORDING TO THE INSTRUCTIONS FOR USE. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONNECTOR C35-O SEPARATED FROM THE INJECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CONNECTION BETWEEN PHASEAL OPTIMA INJECTOR AND PHASEAL CONNECTOR KEEPS POPPING OUT. VERBATIM: PATIENT CAME WITH DISCONNECTED CHEMO PUMP. PUMP IS SUPPOSED TO RUN FOR 24 HOURS STARTING YESTERDAY AT 12:20 UNTIL TODAY ALSO AT AROUND 12:20. PER PATIENT AT AROUND 23:00 THE CONNECTION BETWEEN PHASEAL OPTIMA INJECTOR AND PHASEAL CONNECTOR KEEPS POPPING OUT, SHE TRIED TO RECONNECT, EVEN TRIED TO HOLD THE CONNECTION HERSELF, AND ALSO APPLIED TAKE TO KEEP IT CONNECTED BUT TO NO AVAIL. SHE FINALLY GAVE UP, STOPPED THE PUMPS AND WAITED UNTIL MORNING FOR HER D2 APPOINTMENT.

    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 CONNECTOR C35-O SEPARATED FROM THE INJECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CONNECTION BETWEEN PHASEAL OPTIMA INJECTOR AND PHASEAL CONNECTOR KEEPS POPPING OUT. VERBATIM: PATIENT CAME WITH DISCONNECTED CHEMO PUMP. PUMP IS SUPPOSED TO RUN FOR 24 HOURS STARTING YESTERDAY AT 12:20 UNTIL TODAY ALSO AT AROUND 12:20. PER PATIENT AT AROUND 23:00 THE CONNECTION BETWEEN PHASEAL OPTIMA INJECTOR AND PHASEAL CONNECTOR KEEPS POPPING OUT, SHE TRIED TO RECONNECT, EVEN TRIED TO HOLD THE CONNECTION HERSELF, AND ALSO APPLIED TAKE TO KEEP IT CONNECTED BUT TO NO AVAIL. SHE FINALLY GAVE UP, STOPPED THE PUMPS AND WAITED UNTIL MORNING FOR HER D2 APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321013 CONNECTOR C35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2102506

    Patients

    Seq Age Sex Outcome Treatment
    1