BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INFUSION ADAPTER (C100-0 MULTI)

    MDR report key: 11969339 · Received June 9, 2021

    Report

    Report Number
    3003152976-2021-00322
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150791
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 2012701, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, THERE WAS NO DAMAGE OR OTHER DEFECTS OBSERVED ON THE INFUSION ADAPTER. 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 MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL 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 INFUSION ADAPTER (C100-0 MULTI) FELL OUT OF THE PACKAGING AND ONTO THE FLOOR WHILE HANGING IT ON THE POLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL OPTIMA INFUSION ADAPTOR FELL OUT OF THE BAG AND ONTO THE FLOOR AS NURSE WAS GOING TO HANG IT ON POLE.".

    Additional Manufacturer Narrative · 1

    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 INFUSION ADAPTER (C100-0 MULTI) FELL OUT OF THE PACKAGING AND ONTO THE FLOOR WHILE HANGING IT ON THE POLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL OPTIMA INFUSION ADAPTOR FELL OUT OF THE BAG AND ONTO THE FLOOR AS NURSE WAS GOING TO HANG IT ON POLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865540 BD PHASEAL OPTIMA INFUSION ADAPTER (C100-0 MULTI) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515079 2012701 00382905150791

    Patients

    Seq Age Sex Outcome Treatment
    1