BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P20-O MULTIPACK

    MDR report key: 12097524 · Received June 30, 2021

    Report

    Report Number
    3003152976-2021-00357
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 3, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150654
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/29/2021. H.6. INVESTIGATION: TEN UNUSED PROTECTOR SAMPLES ALONG WITH TEN UNUSED INJECTOR SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE PRODUCT. MOREOVER, ONE PICTURE WAS RECEIVED BY THE CUSTOMER SHOWING ANTISEPTIC ISOPROPYL ALCOHOL WIPES USED (ACCORDING THE VERBATIM OF THE COMPLAINT), FOR DABBING OPTIMA MEMBRANE. HOWEVER; NO PICTURES FROM CLAIMED SAMPLE WERE RECEIVED AND THEREFORE, NO ANALYSIS ON CLAIMED SAMPLE INVOLVED IN THE COMPLAINT CAN BE PERFORMED. NO FINDINGS ARE AVAILABLE AFTER THE EVALUATION OF PICTURE RECEIVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2103406, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING MANUFACTURING, LEAKAGE TESTING IS PERFORMED, PENETRATING THE PROTECTOR TEN TIMES TO VERIFY IF ANY LEAKS OCCUR. TESTING WAS REVIEWED FOR LOT 2103406, ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. LEAKAGE TESTING WAS ALSO PERFORMED ON THE TEN SAMPLES THAT WERE PROVIDED. USING THE RETURNED SAMPLE INJECTORS, THE PROTECTOR MEMBRANE WAS PENETRATED TEN TIMES, ALL SAMPLES MEETING REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROTECTOR P20-O MULTIPACK LEAKED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE SALES REP THAT THERE IS LEAKAGE THROUGH THE MEMBRANE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY: (B)(6). 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 PROTECTOR P20-O MULTIPACK LEAKED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE SALES REP THAT THERE IS LEAKAGE THROUGH THE MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987032 PROTECTOR P20-O MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2103406 00382905150654

    Patients

    Seq Age Sex Outcome Treatment
    1