BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O

    MDR report key: 16097454 · Received January 4, 2023

    Report

    Report Number
    3002682307-2022-00358
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 8, 2022
    Report Date
    February 23, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201504, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. FIVE RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS NO DAMAGE OR OTHER DEFECTS OBSERVED ON ANY OF THE INFUSION ADAPTERS. THE ADAPTERS WERE INSERTED INTO AN INFUSION BAG FILLED WITH RED SOLUTION AND HUNG. AFTER TWENTY-FOUR HOURS OF OBSERVATION, NO ISSUE WERE IDENTIFIED, THE SPIKES REMAINED PROPERLY CONNECTED IN THE INFUSION BAG AND NO LEAKS OCCURRED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THAT ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. ALL RETAINED SAMPLES UNDERWENT THESE EVALUATIONS AND PRODUCT WAS VERIFIED TO MEET REQUIRED LIMITS, INCLUDING PROPER SPIKE LENGTH AND DIAMETER. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O POPPED OUT OF THE BRAUN INFUSION BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BAG SPIKE C100-O HAS POPPED OUT OF THE BRAUN INFUSION BAG - ONLY WITH PACLITAXEL WITH BRAUN BAGS. HAPPENING WITH NO OTHER DRUGS. USING THE BRAUN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O POPPED OUT OF THE BRAUN INFUSION BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BAG SPIKE C100-O HAS POPPED OUT OF THE BRAUN INFUSION BAG---ONLY WITH PACLITAXEL WITH BRAUN BAGS. ---HAPPENING WITH NO OTHER DRUGS. USING THE BRAUN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909328 BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2201504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown