BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP)

    MDR report key: 9071240 · Received September 16, 2019

    Report

    Report Number
    8041187-2019-00728
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    September 1, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9081787. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE DEVICE. BASED ON THEIR EVALUATION AND THE DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD PEGASUS IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP) HAS BEEN FOUND WITH DEFECTIVE TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING THE INTENSIVE CT EXAMINATION, IT'S NOTICED THAT EXT. TUBING DISCONNECTED WITH THE Y-PORT. THE SAMPLE RETURNED IS THE REFERENCE SAMPLE WITH THE SAME BATCH NUMBER DUE TO THE DEFECTED PRODUCT HAS BEEN DISPOSED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP) HAS BEEN FOUND WITH DEFECTIVE TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DURING THE INTENSIVE CT EXAMINATION, IT'S NOTICED THAT EXT. TUBING DISCONNECTED WITH THE Y-PORT THE SAMPLE RETURNED IS THE REFERENCE SAMPLE WITH THE SAME BATCH NUMBER DUE TO THE DEFECTED PRODUCT HAS BEEN DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866469 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9081787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other