BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR (P20-O)

    MDR report key: 9372397 · Received November 25, 2019

    Report

    Report Number
    3003152976-2019-00808
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 6, 2019
    Report Date
    February 20, 2020
    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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO AND ONE SAMPLE IN THE ORIGINAL PACKAGE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTO, THE SPIKE IS OBSERVED TO BE SEPARATED FROM THE PROTECTOR HOUSING, VERIFYING THE REPORTED FAILURE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1902153, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE SAMPLE THAT WAS PROVIDED AND THREE RETAINED SAMPLES LOT 1902153 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE PROTECTORS TO A VIAL, INJECTOR, AND SYRINGE PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. IN ALL CASES, THE SPIKE PROPERLY PENETRATED THE VIAL, LIQUID WAS ABLE TO BE DRAWN FROM THE VIAL, AND THE PRODUCT FUNCTIONED AS INTENDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE 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 HAS BEEN REPORTED THAT ONE BD PHASEAL OPTIMA PROTECTOR (P20-O) HAS BEEN FOUND DAMAGED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE STEM OF THE PROTECTOR HAD BROKEN OFF DURING USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD PHASEAL OPTIMA PROTECTOR (P20-O) HAS BEEN FOUND DAMAGED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE STEM OF THE PROTECTOR HAD BROKEN OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168279 BD PHASEAL OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902153 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other