BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC

    MDR report key: 8355773 · Received February 20, 2019

    Report

    Report Number
    8041187-2019-00163
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 30, 2019
    Report Date
    March 13, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903837175
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REPORT WAS CONDUCTED FOR LOT NUMBER 8170417, AND NO RELATED ABNORMALITIES WERE FOUND. THIS LOT OF PEGASUS 24 GAUGE WAS MANUFACTURED FROM 4/6/2018-4/9/2018, AND THIS IS THE ONLY INSTANCE OF A SAFETY SHIELD ACTIVATION FAILURE OCCURRING IN THIS LOT. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. YOUR FACILITY WAS ABLE TO SUBMIT SAMPLES FOR EVALUATION; BD ENGINEERS WERE ABLE TO OBSERVE A TILTED V-CLIP DURING THE VISUAL OBSERVATION OF THE DEVICE. THE ROOT CAUSE FOR THIS OCCURRENCE IS THE DESIGN OF THIS COMPONENT. SINCE THE MANUFACTURE OF THIS LOT BD HAS OPTIMIZED THE DESIGN TO PREVENT EVENTS SUCH AS THIS FROM OCCURRING IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC HAD A SAFETY SHIELD THAT COULD NOT BE ACTIVATED PROPERLY ACTIVATED AFTER THE CATHETER WAS SUCCESSFULLY PLACED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC HAD A SAFETY SHIELD THAT COULD NOT BE ACTIVATED PROPERLY ACTIVATED AFTER THE CATHETER WAS SUCCESSFULLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149499 PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8170417 00382903837175

    Patients

    Seq Age Sex Outcome Treatment
    1 Other