BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR (P20-O)

    MDR report key: 9174883 · Received October 10, 2019

    Report

    Report Number
    3003152976-2019-00711
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 16, 2019
    Report Date
    November 5, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150647
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE SAMPLES FROM PROTECTOR LOT 1902101 WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED WITH NO DEFECTS OBSERVED. THE SAMPLES WERE FUNCTIONALLY TESTED, CONNECTING A SAMPLE INJECTOR TO THE PROTECTORS ALONG WITH THE VIAL AND A SYRINGE ACCORDING TO THE INSTRUCTIONS FOR USE. IN ALL CASES IT WAS POSSIBLE TO WITHDRAW FLUID FROM THE VIAL, THE EXPANSION CHAMBER FUNCTIONED PROPERLY, AND THE PRODUCT FUNCTIONED AS INTENDED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1902101, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES A SERIES OF INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING FLOW RATE VERIFICATION. TESTING RESULTS FOR LOT 1902101, ALONG WITH THE TESTING PERFORMED ON THE RECEIVED SAMPLES WERE REVIEWED, NO DEFECTS WERE OBSERVED AND PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THERE WAS FLOW ISSUES WITH A BD PHASEAL PROTECTOR P20-O. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: (4 OF 4 COMPLAINTS). IT WAS REPORTED THAT THE MEDICATION WAS HAVING TROUBLE FLOWING COMPLETELY INTO THE VIAL WITH ONE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE NOTICING THAT THE INJECTORS SEEM TO BE PULLING DRUG BACK INTO THE VIAL AFTER WE HAVE DETACHED THE SYRINGE WITH THE AMOUNT WE HAD NEEDED CAUSING US TO HAVE TO BACK INTO THE VIAL A FEW TIMES TO GET THE DESIRED AMOUNT TO STAY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 DURING USE THERE WAS FLOW ISSUES WITH A BD PHASEAL PROTECTOR P20-O. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: (4 OF 4 COMPLAINTS). IT WAS REPORTED THAT THE MEDICATION WAS HAVING TROUBLE FLOWING COMPLETELY INTO THE VIAL WITH ONE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE NOTICING THAT THE INJECTORS SEEM TO BE PULLING DRUG BACK INTO THE VIAL AFTER WE HAVE DETACHED THE SYRINGE WITH THE AMOUNT WE HAD NEEDED CAUSING US TO HAVE TO BACK INTO THE VIAL A FEW TIMES TO GET THE DESIRED AMOUNT TO STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968404 BD PHASEAL OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902101 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other