BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P21J

    MDR report key: 10617046 · Received October 1, 2020

    Report

    Report Number
    3003152976-2020-00429
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 29, 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: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/21/2020. H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, A BROWN PARTICLE WAS OBSERVED ON THE EXPANSION CHAMBER. USING MAGNIFICATION IT WAS IDENTIFIED THE PARTICLE WAS BETWEEN THE LAYERS OF FILM FROM THE EXPANSION CHAMBER. THE FILM USED FOR THE EXPANSION CHAMBER IS PROVIDED BY A SUPPLIER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1912112, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ADDITIONALLY, WE REVIEWED DEVICE RECORDS FOR THE EXPANSION FILM , NO NON-CONFORMANCES WERE IDENTIFIED. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, BASED ON THE LOCATION THE FOREIGN MATTER WAS FOUND, THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO THE MATERIAL PROVIDED BY THE SUPPLIER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE PROTECTOR P21J BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "BEFORE USING P21, THE HCP FOUND FM INSIDE THE EXPANSION CHAMBER."

    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 FOREIGN MATTER WAS FOUND IN THE PROTECTOR P21J BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(4) TO ENGLISH: "BEFORE USING P21, THE HCP FOUND FM INSIDE THE EXPANSION CHAMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075677 PROTECTOR P21J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1912112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other