BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P20-O

    MDR report key: 9294350 · Received November 8, 2019

    Report

    Report Number
    3003152976-2019-00768
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    September 27, 2019
    Report Date
    February 3, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO SHOWING A GREY PARTICLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. WHILE THE PARTICLE MAY BE CONSISTENT WITH THE RUBBER STOPPER, WITHOUT THE ACTUAL SAMPLE WE CANNOT VERIFY THE ORIGIN OF THE PARTICLE OBSERVED. NO PHOTOS OR SAMPLES DISPLAYING THE REPORT ISSUE RELATED TO THE EXPANSION CHAMBER WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 1902153 AND 1903161, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE ISSUES. RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED, THE EXPANSION CHAMBER EXPANDED PROPERLY, LIQUID WAS ABLE TO BE DRAWN FROM THE VIAL, AND THE PRODUCT FUNCTIONED AS INTENDED. FRAGMENTATION TESTING WAS ALSO PERFORMED, NO PARTICLES OR CORING WAS IDENTIFIED. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE PROTECTOR P20-O THERE WAS AN ISSUE WITH FOREIGN MATTER CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACLITAXEL VIAL STOPPER CORED WHEN P20-0 PROTECTOR ATTACHED TO THE VIAL.

    Additional Manufacturer Narrative · 1

    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 WAS REPORTED THAT DURING USE OF THE PROTECTOR P20-O THERE WAS AN ISSUE WITH FOREIGN MATTER CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACLITAXEL VIAL STOPPER CORED WHEN P20-0 PROTECTOR ATTACHED TO THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088665 PROTECTOR P20-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902153 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other