BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P14

    MDR report key: 10119470 · Received June 4, 2020

    Report

    Report Number
    3003152976-2020-00241
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    April 20, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151003
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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: 2020-07-06. H.6. INVESTIGATION SUMMARY. TWO UNUSED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGED WAS IDENTIFIED ON THE PROTECTOR OR PROTECTOR MEMBRANE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1910108, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FUNCTIONAL TESTING WAS PERFORMED ON THE SAMPLE, LIQUID INSIDE THE SYRINGE COULD MOVE TO THE VIAL AND BACK TO THE SYRINGE WITHOUT ISSUE AND NO LEAKS WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. THE PROTECTOR MUST BE ATTACHED COMPLETELY VERTICAL. THE M12 ASSEMBLY FIXTURE IS RECOMMENDED TO EASE THE CONNECTION OF THE PROTECTOR TO THE VIAL. 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 WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P14 LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING P14 PROTECTOR DURING THE KEYTRUDA PREPARATION LEAKAGE OBSERVED. THE LEAK OCCURRED AT THE VIAL ATTACHMENT SITE WITH THE PROTECTOR.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P14 LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING P14 PROTECTOR DURING THE KEYTRUDA PREPARATION LEAKAGE OBSERVED. THE LEAK OCCURRED AT THE VIAL ATTACHMENT SITE WITH THE PROTECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585560 BD PHASEAL PROTECTOR P14 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515100 1910108 30382905151003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other