BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR (P50 MULTI)

    MDR report key: 10347796 · Received July 30, 2020

    Report

    Report Number
    3003152976-2020-00324
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    50382905151069
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PRODUCT, BLACK PARTICLES WERE OBSERVED UNDER THE FILM OF THE EXPANSION CHAMBER. USING MAGNIFICATION, THE PARTICLES WERE DETERMINED TO BE CARBON DEPOSITS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2001112, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER AND PERFORM CLEARLY DEFINED CLEANING ACCORDING TO PROCEDURE . ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THESE DEPOSITS GENERATED DURING THE SEALING PROCESS OF THE FILM ONTO THE PROTECTOR BLADDER IN THE ASSEMBLY MACHINE. CLEARANCE OF THE ASSEMBLY LINES IS PERFORMED ACCORDING TO PROCEDURE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK DUST WAS FOUND IN THE BD PHASEAL¿ PROTECTOR (P50 MULTI) BEFORE USE WHILE UNPACKING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "BLACK DUST (FM) WAS FOUND IN THE PROTECTOR WHEN UNPACKING.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK DUST WAS FOUND IN THE BD PHASEAL¿ PROTECTOR (P50 MULTI) BEFORE USE WHILE UNPACKING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "BLACK DUST (FM) WAS FOUND IN THE PROTECTOR WHEN UNPACKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812641 BD PHASEAL PROTECTOR (P50 MULTI) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515106 2001112 50382905151069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other