BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P50 MULTIPACK

    MDR report key: 10469430 · Received August 29, 2020

    Report

    Report Number
    3003152976-2020-00390
    Event Type
    Malfunction
    Date Received
    August 29, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 29, 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: TWO PHOTOS AND ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF BOTH THE PHOTOS AND PRODUCT RETURNED, A HAIR WAS OBSERVED UNDER THE FILM OF THE EXPANSION CHAMBER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2001145, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROTECTOR P50 MULTIPACK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, HAIR-LIKE FM WAS FOUND IN THE EXPANSION CHAMBER OF P50 BEFORE USE.

    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 THE PROTECTOR P50 MULTIPACK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, HAIR-LIKE FM WAS FOUND IN THE EXPANSION CHAMBER OF P50 BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934047 PROTECTOR P50 MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515106 2001145 50382905151069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other