BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13167795 · Received January 5, 2022

    Report

    Report Number
    3014704491-2021-00412
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    November 26, 2021
    Report Date
    December 14, 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 0231174. 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    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS FOUND SPLIT WHEN THE NEEDLE WAS WITHDRAWN AFTER THE FAILED PUNCTURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) : "AT 15:00 ON (B)(6) 2021, THE PATIENT WENT TO HOSPITAL BECAUSE OF PREGNANCY AND REQUIRED ABORTION. BEFORE SURGERY, VENOUS INDWELLING WAS PERFORMED ACCORDING TO THE DOCTOR'S ADVICE. AT 15:10, THE VENOUS INDWELLING PUNCTURE FAILED, AND THE CATHETER TUBE SPLIT WAS FOUND WHEN THE NEEDLE WAS WITHDRAWN. A NEW CLOSED VEIN INDWELLING NEEDLE WAS IMMEDIATELY REPLACED AND THE PUNCTURE WAS SUCCESSFUL. THIS INCIDENT BROUGHT PSYCHOLOGICAL HARM TO THE PATIENT, AND NO INSTRUMENTS WERE USED TOGETHER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512196 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0231174

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown