BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P50J

    MDR report key: 10856985 · Received November 17, 2020

    Report

    Report Number
    3003152976-2020-00508
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 21, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-30. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTO, A HAIR WAS OBSERVED UNDER THE FILM OF THE EXPANSION CHAMBER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE SUSPECTED LOTS 2002130, 2002136, 2003103, 2003141, AND 2003142, 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, THE ROOT CAUSE OF THIS INCIDENT IS LIKELY DUE TO PERSONNEL NOT FOLLOWING THE PROPER GOWNING PROCEDURE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P50J HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT FM FOUND WHEN UNPACKING. BDJ CONFIRMED A BLACK FM INSIDE OF BLADDER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P50J HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT FM FOUND WHEN UNPACKING. BDJ CONFIRMED A BLACK FM INSIDE OF BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322983 BD PHASEAL PROTECTOR P50J PROTECTOR ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1