BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P28

    MDR report key: 9641029 · Received January 29, 2020

    Report

    Report Number
    3003152976-2020-00019
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 7, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151041
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ELEVEN UNUSED PROTECTOR SAMPLES WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE IDENTIFIED ON ANY OF THE PRODUCTS. ALL SAMPLES WERE FUNCTIONALLY TESTED. THE PROTECTORS WERE SUCCESSFULLY CONNECTED TO THE VIALS, ENSURING THEY FIT PROPERLY. THE PROTECTORS WERE THEN CONNECTED TO AN INJECTOR AND SYRINGE WITHOUT ISSUES AND NO LEAKS WERE OBSERVED. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCE'S RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1810124. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING. TEST RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND TO BE WITHIN SPECIFICATION. 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 LEAKAGE OCCURRED BETWEEN THE PROTECTOR AND VIAL WITH A BD PHASEAL¿ PROTECTOR P28. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A LEAK OCCURRED BETWEEN THE PROTECTOR AND THE VIAL. ADDITIONAL INFORMATION PROVIDED 2020-01-16: Q: - THE INVESTIGATION TEAM WOULD LIKE TO KNOW HOW THE PROTECTOR WAS ATTACHED TO THE VIAL: WAS IT PLACED MANUALLY ON THE VIAL OR WAS THE PHASEAL ASSEMBLY FIXTURE BEING USED? A: - THE DEVICE WAS PLACED MANUALLY BY THE COMPOUNDING TECHNICIAN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 LEAKAGE OCCURRED BETWEEN THE PROTECTOR AND VIAL WITH A BD PHASEAL¿ PROTECTOR P28. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A LEAK OCCURRED BETWEEN THE PROTECTOR AND THE VIAL. ADDITIONAL INFORMATION PROVIDED 2020-01-16: THE INVESTIGATION TEAM WOULD LIKE TO KNOW HOW THE PROTECTOR WAS ATTACHED TO THE VIAL: WAS IT PLACED MANUALLY ON THE VIAL OR WAS THE PHASEAL ASSEMBLY FIXTURE BEING USED? THE DEVICE WAS PLACED MANUALLY BY THE COMPOUNDING TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108369 BD PHASEAL PROTECTOR P28 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515104 1810124 30382905151041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other