BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS IV CATHETER

    MDR report key: 16660673 · Received March 31, 2023

    Report

    Report Number
    3014704491-2023-00086
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 10, 2023
    Manufacturer
    BD (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

    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

    H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2200037. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS IV CATHETER EXPERIENCED PRN SEPARATION FROM THE ADAPTER AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PATIENT CAME TO THE HOSPITAL FOR ENHANCED CT ON (B)(6) 2023, THE NURSING STAFF FOLLOWED THE DOCTOR'S INSTRUCTIONS AND FOLLOWED THE OPERATION PROCEDURE TO PLACE AN INTRAVENOUS CATHETER. WHEN THE CONTRAST AGENT IS INJECTED AT HIGH PRESSURE, THE PRN OF THE PRODUCT'S INDWELLING NEEDLE IS WASHED AWAY BY THE PRESSURE, WHICH CAUSES THE CONTRAST AGENT DRUG NOT TO ENTER THE PATIENT'S BLOOD VESSEL, AND THEN THE PATIENT'S BLOOD FLOWS BACK WITH THE INDWELLING NEEDLE. THE STAFF IMMEDIATELY STOPPED THE EXAMINATION AND EXTUBATED THE TUBE FOR DISINFECTION AND HEMOSTASIS. ABOUT HALF AN HOUR AFTER APPEASING THE PATIENT, THE CLOSED NEEDLE-STICK PREVENTION INTRAVENOUS INDWELLING NEEDLE (SAME TYPE AND SPECIFICATION) WAS REPLACED AGAIN. THE ENHANCED CT EXAMINATION DID NOT SHOW THE SAME ADVERSE EVENTS. THE OCCURRENCE OF THIS INCIDENT CAUSED THE PATIENT'S BLOOD REFLUX AND WASTE OF CONTRAST MEDIUM TO CAUSE POLLUTION. THE PATHOGENS ON THE CONTAMINATED PRN COULD EASILY CAUSE SYSTEMIC INFECTION THROUGH BLOOD CIRCULATION. THE INCIDENT WAS THEN REPORTED TO THE EQUIPMENT DIVISION FOR PROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS IV CATHETER EXPERIENCED PRN SEPARATION FROM THE ADAPTER AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PATIENT CAME TO THE HOSPITAL FOR ENHANCED CT ON (B)(6) 2023, THE NURSING STAFF FOLLOWED THE DOCTOR'S INSTRUCTIONS AND FOLLOWED THE OPERATION PROCEDURE TO PLACE AN INTRAVENOUS CATHETER. WHEN THE CONTRAST AGENT IS INJECTED AT HIGH PRESSURE, THE PRN OF THE PRODUCT'S INDWELLING NEEDLE IS WASHED AWAY BY THE PRESSURE, WHICH CAUSES THE CONTRAST AGENT DRUG NOT TO ENTER THE PATIENT'S BLOOD VESSEL, AND THEN THE PATIENT'S BLOOD FLOWS BACK WITH THE INDWELLING NEEDLE. THE STAFF IMMEDIATELY STOPPED THE EXAMINATION AND EXTUBATED THE TUBE FOR DISINFECTION AND HEMOSTASIS. ABOUT HALF AN HOUR AFTER APPEASING THE PATIENT, THE CLOSED NEEDLE-STICK PREVENTION INTRAVENOUS INDWELLING NEEDLE (SAME TYPE AND SPECIFICATION) WAS REPLACED AGAIN. THE ENHANCED CT EXAMINATION DID NOT SHOW THE SAME ADVERSE EVENTS. THE OCCURRENCE OF THIS INCIDENT CAUSED THE PATIENT'S BLOOD REFLUX AND WASTE OF CONTRAST MEDIUM TO CAUSE POLLUTION. THE PATHOGENS ON THE CONTAMINATED PRN COULD EASILY CAUSE SYSTEMIC INFECTION THROUGH BLOOD CIRCULATION. THE INCIDENT WAS THEN REPORTED TO THE EQUIPMENT DIVISION FOR PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773697 BD PEGASUS IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2200037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown