BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13839799 · Received March 21, 2022

    Report

    Report Number
    3014704491-2022-00107
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    December 12, 2021
    Report Date
    April 1, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. 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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230569. 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. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM PRN SEPARATED FROM THE ADAPTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "AT 15:00, ON (B)(6) 2021, ACCORDING TO CLINICAL REQUIREMENTS, WHEN THE NURSE USED THE INTRAVENOUS INDWELLING NEEDLE, AFTER THE NEEDLE ENTERED THE PATIENT'S SUBCUTANEOUS TISSUE, THE NEEDLE CAP OF THE INDWELLING NEEDLE WAS SEPARATED FROM THE NEEDLE, SO IT COULD NOT BE CONTINUED TO BE USED. PULL OUT THE NEEDLE IMMEDIATELY, REPLACE AND REOPEN THE INTRAVENOUS INDWELLING NEEDLE. NO ADVERSE REACTIONS WERE OBSERVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM PRN SEPARATED FROM THE ADAPTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT 15:00, ON (B)(6) 2021, ACCORDING TO CLINICAL REQUIREMENTS, WHEN THE NURSE USED THE INTRAVENOUS INDWELLING NEEDLE, AFTER THE NEEDLE ENTERED THE PATIENT'S SUBCUTANEOUS TISSUE, THE NEEDLE CAP OF THE INDWELLING NEEDLE WAS SEPARATED FROM THE NEEDLE, SO IT COULD NOT BE CONTINUED TO BE USED. PULL OUT THE NEEDLE IMMEDIATELY, REPLACE AND REOPEN THE INTRAVENOUS INDWELLING NEEDLE. NO ADVERSE REACTIONS WERE OBSERVED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545237 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1230569

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown