BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SPIKE CONNECTOR (C180J)

    MDR report key: 16030310 · Received December 21, 2022

    Report

    Report Number
    3003152976-2022-00579
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 2, 2022
    Report Date
    February 1, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SPIKE IS OBSERVED TO BE BROKEN OFF OF THE UPPER BASED. FURTHER EVALUATION DID NOT IDENTIFY ANY AIR BUBBLES OR OTHER DEFECTS THAT WOULD HAVE LED TO THE BREAKAGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201210, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, NO ISSUES WERE IDENTIFIED. BASED ON THE SAMPLE EVALUATION, THE ROOT CAUSE WAS DETERMINED TO BE THE FORCE USED WHEN INSERTING THE SPIKE CONNECTOR INTO THE IV BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) EXPERIENCED A BROKEN TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE (SPIKE) OF 180J BROKE OFF FROM ITS BASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR (C180J) EXPERIENCED A BROKEN TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE (SPIKE) OF 180J BROKE OFF FROM ITS BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858034 BD PHASEAL¿ SPIKE CONNECTOR (C180J) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2201210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown