BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P14

    MDR report key: 15210639 · Received August 11, 2022

    Report

    Report Number
    3003152976-2022-00365
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    July 19, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905151002
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 15-OCT-2022. H6: INVESTIGATION SUMMARY: TWO UNUSED SAMPLES OF LOT 2111120 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE WAS OBSERVED ON THE CANNULA OR IN THE AREA WHERE IT ASSEMBLES INTO THE PROTECTOR HOUSING THAT WOULD INDICATE IMPROPER ASSEMBLY. FUNCTIONAL TESTS WERE PERFORMED, CONNECTING THE PROTECTOR TO A VIAL USING THE M12 ASSEMBLY FIXTURE, AS WELL AS TO A SAMPLE INJECTOR AND A SYRINGE. IN ALL CASES, THE PROTECTOR FITTED CORRECTLY TO THE VIAL, THE LIQUID COULD BE WITHDRAWN FROM THE VIAL AND THE PRODUCT FUNCTIONED AS INTENDED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR RECEIVED LOT 2111120, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING, ACCORDING TO PROCEDURE TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, NO ISSUES WERE FOUND DURING PRODUCTION OF LOT 2111120. BASED ON OUR INVESTIGATION AND SAMPLE EVALUATION, WE ARE UNABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PHASEAL IS LEAKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PHASEAL IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382185 BD PHASEAL¿ PROTECTOR P14 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 00382905151002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown