BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 12260644 · Received August 2, 2021

    Report

    Report Number
    3014704491-2021-00056
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    June 11, 2021
    Report Date
    July 27, 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

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231225. 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, ALTHOUGH A SAMPLE WAS NOT PROVIDED BY THE FACILITY FOR EVALUATION, PREVIOUS INVESTIGATIONS HAVE SHOWN THAT A LARGE BEND SUGGESTS A LARGE FORCE WAS APPLIED TO THE PACKAGING UNIT AFTER THE DEVICE HAD LEFT THE MANUFACTURING FACILITY, MOST LIKELY DURING SHIPPING. THE SHIPPING COMPANY HAS BEEN NOTIFIED OF THE SITUATION AND BD STANDARDS AND EXPECTATIONS HAVE BEEN RECOMMUNICATED. BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II CLOSED IV CATHETER SYSTEM TIP WAS DAMAGED/DEFORMED AND COULDN'T BE USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE NURSE ON DUTY FOUND THAT THE 24G CLOSED INTRAVENOUS INDWELLING NEEDLE WAS DEFORMED BEFORE VENIPUNCTURE AND COULD NOT BE USED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154847 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0231225

    Patients

    Seq Age Sex Outcome Treatment
    1