BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA CONNECTOR (C35-O)

    MDR report key: 11891302 · Received May 26, 2021

    Report

    Report Number
    3003152976-2021-00290
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 29, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 2011503. D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2022. H.4. DEVICE MANUFACTURE DATE: 1/11/2020. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/26/2021. INVESTIGATION: ONE UNUSED OPTIMA INJECTOR, LOT 2011318, AND ONE UNUSED CONNECTOR, LOT 2011503, AND ONE B. BRAUN IV SET WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DAMAGE OR OTHER DEFECTS WERE OBSERVED ON AND OF THE PRODUCT OR LUER CONNECTIONS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2011503 AND 2011318, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS, INCLUDING TESTING TO VERIFY ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION SUCH AS THE LUER THREADING. ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. FIVE RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION, NO DAMAGE WAS OBSERVED ON THE PRODUCT AND ALL LUER DIMENSIONS WERE VERIFIED TO BE WITHIN THE REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA CONNECTOR (C35-O) EXPERIENCED SEPARATION OF CONNECTOR AND LUER MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515070 BATCH NO: UNKNOWN. ONCOLOGY NURSE EDUCATOR CONTACTED TERRITORY REP VIA EMAIL TO COMMUNICATE A BREAK (DISCONNECTION) IN THEIR SYSTEM WHILE USING THE CSTD AT THE PATIENT CONNECTION. THE BREAK OCCURRED AT THE ASV VALVE ON THE TUBING. HAPPENED DURING A PEG- ASP YESTERDAY DUE TO THE REACTIVE NATURE OF THE DRUG AND WANTING IT AT THE END OF THE LINE. ONCOLOGY NURSE EDUCATOR COMMUNICATED THIS WAS RELATED TO THE ASV AND THE POOR LEUR CONNECTION AND NOT A FAILURE IN PHASEAL OPTIMA.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL OPTIMA CONNECTOR (C35-O) EXPERIENCED SEPARATION OF CONNECTOR AND LUER MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515070, BATCH NO: UNKNOWN . ONCOLOGY NURSE EDUCATOR CONTACTED TERRITORY REP VIA EMAIL TO COMMUNICATE A BREAK (DISCONNECTION) IN THEIR SYSTEM WHILE USING THE CSTD AT THE PATIENT CONNECTION. THE BREAK OCCURRED AT THE ASV VALVE ON THE TUBING. HAPPENED DURING A PEG- ASP YESTERDAY DUE TO THE REACTIVE NATURE OF THE DRUG AND WANTING IT AT THE END OF THE LINE. ONCOLOGY NURSE EDUCATOR COMMUNICATED THIS WAS RELATED TO THE ASV AND THE POOR LEUR CONNECTION AND NOT A FAILURE IN PHASEAL OPTIMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786782 BD PHASEAL OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2011503

    Patients

    Seq Age Sex Outcome Treatment
    1