BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8000319 · Received October 24, 2018

    Report

    Report Number
    3006948883-2018-00234
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 4, 2018
    Report Date
    November 2, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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

    A DEVICE HISTORY REPORT WAS CONDUCTED FOR LOT NUMBER 8141412. DURING OUR REVIEW, NO ABNORMALITIES RELATED TO THIS EVENT WERE FOUND TO HAVE OCCURRED DURING OUR MONITORING OF THE MANUFACTURING PROCESS. ACCORDING TO OUR RECORDS THIS LOT OF INTIMA II WAS MANUFACTURED JUNE 2018, AND THIS IS THE ONLY INSTANCE OF A LEAKAGE AT LUER CONNECTION OCCURRING IN THIS LOT. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. A SAMPLE HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION CONCLUSION: BD ENGINEERS EVALUATED THE RETURNED DEVICE, AND FOUND THE ROOT CAUSE FOR THIS EVENT TO BE A LOOSE PORT ON THE DEVICE. THIS ISSUE HAS BEEN KNOWN TO BE CAUSED BY THE TRANSPORTATION AND STORAGE OF THE DEVICE. THE INSTRUCTION FOR USE FOR THIS THE INTIMA II RECOMMEND THAT ALL UNITS BE TIGHTENED PRIOR TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE LUER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE LUER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843359 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 8141412 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other