BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 16514165 · Received March 9, 2023

    Report

    Report Number
    3014704491-2023-00041
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 15, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1110756. 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, A SAMPLE WAS SUBMITTED TO OUR FACILITY TO AID IN OUR INVESTIGATION. THE RETURNED DEVICE WAS SUBJECTED TO PRESSURIZED FUNCTIONAL TESTING AND FOUND TO PERFORM WITHIN SPECIFIED PARAMETERS (300 POUNDS PER SQUARE INCH OF PRESSURE0. BASED ON THE DESCRIPTION OF THE EVENT, OUR ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION WHICH EXCEED PRODUCT SPECIFICATIONS. THE BD PEGASUS IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING HIGH PRESSURE INFUSION WITH BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THE TUBING SEPARATED FROM THE LUER CONNECTOR AND LEAKAGE OCCURRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PROBLEM OCCURRED DURING THE USE OF THE PRODUCT WAS NOT THAT THE EXTENSION TUBE BURST DURING HIGH-PRESSURE INFUSION, BUT THAT THE LUER CONNECTOR FLEW OUT DURING HIGH-PRESSURE INFUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING HIGH PRESSURE INFUSION WITH BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THE TUBING SEPARATED FROM THE LUER CONNECTOR AND LEAKAGE OCCURRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PROBLEM OCCURRED DURING THE USE OF THE PRODUCT WAS NOT THAT THE EXTENSION TUBE BURST DURING HIGH-PRESSURE INFUSION, BUT THAT THE LUER CONNECTOR FLEW OUT DURING HIGH-PRESSURE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706441 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1110756

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown