BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 16583496 · Received March 21, 2023

    Report

    Report Number
    3014704491-2023-00065
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 3, 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

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2140985. 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, 5 UNUSED REPRESENTATIVE SAMPLES WERE RETURNED TO OUR FACILITY TO AID IN OUR INVESTIGATION. VISUAL ANALYSIS OF THE DEVICES WAS CONDUCTED, AND THEY WERE FOUND TO BE FREE OF ANY DAMAGE OR ANY OBSERVABLE ABNORMALITIES. UNFORTUNATELY WITHOUT THE ABILITY TO OBSERVE THE REPORTED NON-CONFORMANCE, OUR ENGINEERS WERE NOT ABLE TO MAKE A DETERMINATION OF THE ROOT CAUSE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM BENT INSIDE THE BLOOD VESSEL DURING THE INFUSION. THIS OCCURRED WITH 5 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON THE SECOND DAY AFTER THE PUNCTURE, WHEN THE CATHETER WAS PULLED OUT, IT WAS FOUND THAT THE MIDDLE SECTION OF THE CATHETER WAS BENT IN THE BLOOD VESSEL, WHICH DID NOT CAUSE ANY HARM TO THE PATIENT, SO IT WAS RE-INDWELLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18220 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2140985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown