BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50J

    MDR report key: 8206070 · Received December 31, 2018

    Report

    Report Number
    3003152976-2018-00569
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 11, 2018
    Report Date
    January 22, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH VISUAL INSPECTION OF THE SAMPLE, A PIECE OF HAIR WAS FOUND WITHIN THE EXPANSION CHAMBER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE PROVIDED LOT NUMBER (1804125) AND THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. PHASEAL PRODUCTS ARE MANUFACTURING AND ASSEMBLED IN A DESIGNATED CLEAN AREA. PERSONNEL ARE REQUIRED TO FOLLOW STRICT GOWNING AND PREVENTIVE PROCEDURES PRIOR TO ENTERING THE CLEAN AREA. TO IMPROVE THE CLEANING OF THE LINES, A PROJECT WAS OPEN ON FY¿18 (#1436). THE PROJECT INCLUDED NEW CLEANING FREQUENCIES AND RE-TRAINING OF THE PERSONNEL IN THE AREA. THE PROJECT HAS DECREASED THE NUMBER OF COMPLAINTS RELATED TO FM. THE LOT WAS MANUFACTURED WHEN THE IMPROVEMENTS WERE BEING LAUNCHED. PERSONNEL OF THE AREA HAS BEEN AWARE OF THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "HAIR LIKE" FOREIGN MATTER WAS FOUND IN THE BD PHASEAL¿ PROTECTOR P50J.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "HAIR LIKE" FOREIGN MATTER WAS FOUND IN THE BD PHASEAL¿ PROTECTOR P50J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045950 BD PHASEAL¿ PROTECTOR P50J PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON, S.A. 1804125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other