BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13048052 · Received December 20, 2021

    Report

    Report Number
    3014704491-2021-00370
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 3, 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: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1051514. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLUID LEAKED BETWEEN THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM AND HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "AT 12:04 ON (B)(6) 2020, THE PATIENT WAS ORDERED TO PERFORM INTRAVENOUS INFUSION AND VENIPUNCTURE. WHEN THE RESPONSIBLE NURSE PERFORMED THE PUNCTURE ON THE PATIENT, THE PUNCTURE WAS SUCCESSFULLY, BLOOD WAS DRAWN BACK, AND FLUID LEAKED FROM THE INDWELLING NEEDLE HANDLE WHEN THE INFUSION FLUID WAS CONNECTED. , CHECK THE VENOUS ACCESS, THE CONNECTION IS TIGHT, THERE IS STILL LEAKAGE, THE INDWELLING NEEDLE IS REMOVED, THE INDWELLING NEEDLE IS REPLACED AND PUNCTURED AGAIN, THE VEIN IS UNOBSTRUCTED, THERE IS NO LEAKAGE OF FLUID AGAIN, AND NO HARM TO THE PATIENT IS CAUSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944576 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1051514

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown