BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12782909 · Received November 9, 2021

    Report

    Report Number
    3014704491-2021-00250
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 21, 2021
    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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050046. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY 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 WHEN USING THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM, THE DEVICE EXPERIENCED THE TUBING CLAMP BEING LOOSE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON (B)(6) 2021, THE PATIENTS IN BED 6 OF WARD 1 WERE GIVEN INTRAVENOUS INFUSION ACCORDING TO THE DOCTOR'S ADVICE. AFTER THE INFUSION, THE TUBE WAS IRRIGATED AND SEALED, AND THE INDWELLING NEEDLE CLIPS WERE CLAMPED. OBVIOUS BLOOD APPEARED AT THE EXTENSION TUBE OF THE Y JOINT OF THE INDWELLING NEEDLE, WHICH STILL APPEARED AFTER THE FLUSHING AND SEALING TUBE WAS CONTINUED TO CLAMP. IN ORDER TO AVOID THROMBOSIS CAUSED BY TUBE BLOCKAGE, THE INDWELLING NEEDLE WAS REMOVED AND INDWELLED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677913 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1050046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown