BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 12344985 · Received August 19, 2021

    Report

    Report Number
    8041187-2021-00749
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 7, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1021750. 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. 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. THE BD PEGASUS IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. BD ENCOURAGES THE REVIEW OF THE INSTRUCTIONS FOR USE INCLUDED WITH ALL PEGASUS UNITS; BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IODINE CONTRAST AGENT LEAKED FROM THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM'S BUST TUBE DURING THE HIGH-PRESSURE INJECTION OF THE CT EXAM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6)TO ENGLISH: "THE PATIENT UNDERWENT CT ENHANCED EXAMINATION AT 5:00 P.M. ON (B)(6) 2021, AND 90ML OF IODINE CONTRAST AGENT WAS INJECTED THROUGH A BD INDWELLING NEEDLE AT 20G HIGH PRESSURE, WITH AN AVERAGE PRESSURE OF 120PSI. DURING THE INJECTION, ABOUT 20ML OF IODINE CONTRAST AGENT LEAKED FROM THE BURST TUBE, AND THE EXAMINATION WAS SUCCESSFULLY COMPLETED WITHOUT ADVERSE CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239835 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ 1021750

    Patients

    Seq Age Sex Outcome Treatment
    1