BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 15008703 · Received July 13, 2022

    Report

    Report Number
    3014704491-2022-00274
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 13, 2022
    Report Date
    July 1, 2022
    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 2011039. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER BURST DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "RADIOLOGISTS FOUND THAT PART OF THE INDWELLING NEEDLE INFUSION SET WAS INSERTED AND BURST WHEN THEY WERE USING THE CLOSED VENOUS INDWELLING NEEDLE FOR INFUSION OF PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470264 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2011039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown