BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8227540 · Received January 8, 2019

    Report

    Report Number
    3006948883-2018-00348
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233349 OUR RECORDS DETERMINED THAT THIS IS THE ONLY INSTANCE OF AN OCCLUDED DEVICE 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 ONE USED SAMPLE WAS RETURNED. OUR INVESTIGATORS NOTED A SMALL CRACK WAS FOUND DURING LEAKAGE TESTING, THAT WAS LOCATED ON THE ADAPTER. THE CRACK MAY BE RELATED TO THE SWAGE DEPTH AND CATHETER ADAPTER DIMENSION. IT MAY ALSO BE RELATED TO THE SWAGE STATION PRODUCTION LINE. WE ARE CURRENTLY CONDUCTING A LONG TERM STUDY TO DETERMINE THE ROOT CAUSE FOR THIS EVENT; PRELIMINARY RESULTS SUGGEST THAT THE Y-ADAPTER CRACK IS CAUSED BY THE EXCESSIVE INTERFERENCE BETWEEN THE Y-ADAPTER AND THE METAL WEDGE. THE PLANT HAS INITIATED CAPA 64273.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A CRACK AT THE JUNCTION OF THE TUBING AND ADAPTOR RESULTING IN LEAKAGE AFTER USE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED A CRACK AT THE JUNCTION OF THE TUBING AND ADAPTOR RESULTING IN LEAKAGE AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22161 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233349

    Patients

    Seq Age Sex Outcome Treatment
    1 Other