BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SECONDARY SET C61

    MDR report key: 8663375 · Received June 3, 2019

    Report

    Report Number
    2243072-2019-01076
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR REVIEW WAS DONE AND NO ISSUES WERE REPORTED DURING PRODUCTION OF THIS LOT. NO SAMPLE RECEIVED FOR THIS COMPLAINT, PICTURE WAS NOT PROVIDED. CT SCAN WAS DONE ON LEAKING SAMPLE WHICH WAS SEGREGATED DURING PRODUCTION. AFTER THIS SCAN ADDITIONAL TESTS WERE DONE ON SPIKE COMPONENT AND CONCENTRICITY OF LOWER PART OF SPIKE COMPONENT CAUSED MOLDING DEFICIT ONE ONE SIDE OF COMPONENT. CAPA#891423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SECONDARY SET C61 LEAKED FROM BETWEEN THE SPIKE AND THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING OF THE SET AT THE WELD BETWEEN THE SPIKE AND THE TUBING."

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). DEVICE EVALUATED BY MFR: 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 THE BD PHASEAL¿ SECONDARY SET C61 LEAKED FROM BETWEEN THE SPIKE AND THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING OF THE SET AT THE WELD BETWEEN THE SPIKE AND THE TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454959 BD PHASEAL¿ SECONDARY SET C61 INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 1011186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other