BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 17293095 · Received July 10, 2023

    Report

    Report Number
    3014704491-2023-00333
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 30, 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3080105. 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.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H3. 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 WHILE USING THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THERE WAS LEAKAGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: IN THE DEPARTMENT OF RADIOLOGY, WHEN A NURSE IS PUTTING AN INDWELLING NEEDLE ON A PATIENT FOR CONTRAST EXAMINATION, THE ISOLATION PLUG OF THE INDWELLING NEEDLE FALLS OFF, CAUSING BLOOD AND CONTRAST AGENT TO FLOW OUT OF THE BODY. IT DID NOT AFFECT THE MEDICAL STAFF, AND THE RESULTS OF THE PATIENT'S ANGIOGRAPHIC EXAMINATION WERE INCORRECT, SO A NEW EXAMINATION WAS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THERE WAS LEAKAGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: IN THE DEPARTMENT OF RADIOLOGY, WHEN A NURSE IS PUTTING AN INDWELLING NEEDLE ON A PATIENT FOR CONTRAST EXAMINATION, THE ISOLATION PLUG OF THE INDWELLING NEEDLE FALLS OFF, CAUSING BLOOD AND CONTRAST AGENT TO FLOW OUT OF THE BODY. IT DID NOT AFFECT THE MEDICAL STAFF, AND THE RESULTS OF THE PATIENT'S ANGIOGRAPHIC EXAMINATION WERE INCORRECT, SO A NEW EXAMINATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170793 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080105

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown