BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8204412 · Received December 28, 2018

    Report

    Report Number
    3006948883-2018-00339
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 13, 2018
    Report Date
    January 10, 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

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED DURING USE. INVESTIGATION SUMMARY: A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233343 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. ROOT CAUSE DESCRIPTION: BD IS CURRENTLY CONDUCTING A LONG TERM STUDY TO DETERMINE THE ROOT CAUSE FOR THIS EVENT. PRELIMINARY RESULTS SUGGEST THAT A MISALIGNMENT IN THE MANUFACTURING MACHINERY MAY BE RESPONSIBLE FOR THIS EVENT. RATIONALE: BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    T WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED DURING 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 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WERE LEAKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044284 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other