BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION SET (C61)

    MDR report key: 8524267 · Received April 17, 2019

    Report

    Report Number
    2243072-2019-00743
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 9, 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 PROVIDED. CT SCAN WAS PERFORMED 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 ON ONE SIDE OF COMPONENT. CAPA# (B)(4) WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE 5 OCCURRENCES OF LEAKING WITH A BD PHASEAL¿ INFUSION SET (C61). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD NOW 5 LEAKING C61¿S FOUND IN PRODUCTION FROM LOT 1011186. THIS LEAK SEEMS TO BE COMING FROM NEAR THE WELD POINT AND THE MAIN PLASTIC BODY.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. (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 THERE WERE 5 OCCURRENCES OF LEAKING WITH A BD PHASEAL¿ INFUSION SET (C61). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD NOW 5 LEAKING C61¿S FOUND IN PRODUCTION FROM LOT 1011186. THIS LEAK SEEMS TO BE COMING FROM NEAR THE WELD POINT AND THE MAIN PLASTIC BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318550 BD PHASEAL¿ INFUSION SET (C61) ADMINISTRATION SET FPA BECTON DICKINSON 1011186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other