BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR (P20-O)

    MDR report key: 10353988 · Received August 1, 2020

    Report

    Report Number
    3003152976-2020-00328
    Event Type
    Malfunction
    Date Received
    August 1, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 14, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150647
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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 1910105, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PROTECTORS WERE SUCCESSFULLY CONNECTED TO THE VIALS ACCORDING TO THE INSTRUCTIONS FOR USE. FUNCTIONAL TESTING WAS PERFORMED, LIQUID WAS SUCCESSFULLY WITHDRAWN FROM THE VIAL AND NO LEAKAGES WERE OBSERVED. PRODUCT UNDERGOES A SERIES OF INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. TESTING RESULTS WERE REVIEWED FOR LOT 1910105 AND NO INCIDENTS WERE OBSERVED DURING TESTING. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PHASEAL OPTIMA PROTECTORS (P20-O) EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OUT OF 4. WHILE PREPARING CHEMOTHERAPY DRUGS, THE PROTECTOR PARTIALLY DISCONNECTED FROM THE VIAL WHILE ASPIRATING THE DRUGS INTO THE SYRINGE USING THE PHASEAL OPTIMA SYSTEM. PLASTIC CLIPS/PARTS THAT CLICKS ON THE VIAL, DISENGAGED FROM THE VIAL WHEN WE BROUGHT THE VIAL IN AN UPRIGHT DIRECTION, TO ASPIRATE THE DRUG FROM THE VIAL. ME, AS A BD CLINICAL CONSULTANT WAS THERE WHILE THE INCIDENT HAPPENED. I CAN ACKNOWLEDGE THAT THE PROTECTOR HAD BEEN FITTED AT THE VIAL CORRECTLY BEFORE THE PREPARATION OF DRUGS STARTED. THERE WAS NO EXPOSURE TO CHEMOTHERAPY.

    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 2 BD PHASEAL OPTIMA PROTECTORS (P20-O) EXPERIENCED LEAKAGE BETWEEN THE PROTECTOR AND VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OUT OF 4 WHILE PREPARING CHEMOTHERAPY DRUGS, THE PROTECTOR PARTIALLY DISCONNECTED FROM THE VIAL WHILE ASPIRATING THE DRUGS INTO THE SYRINGE USING THE PHASEAL OPTIMA SYSTEM. PLASTIC CLIPS/PARTS THAT CLICKS ON THE VIAL, DISENGAGED FROM THE VIAL WHEN WE BROUGHT THE VIAL IN AN UPRIGHT DIRECTION, TO ASPIRATE THE DRUG FROM THE VIAL. ME, AS A BD CLINICAL CONSULTANT WAS THERE WHILE THE INCIDENT HAPPENED. I CAN ACKNOWLEDGE THAT THE PROTECTOR HAD BEEN FITTED AT THE VIAL CORRECTLY BEFORE THE PREPARATION OF DRUGS STARTED. THERE WAS NO EXPOSURE TO CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818166 BD PHASEAL OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1910105 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other