BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER 24G X 0.75 IN.

    MDR report key: 6998009 · Received November 2, 2017

    Report

    Report Number
    3006948883-2017-00080
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 8, 2017
    Report Date
    December 3, 2017
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K100775
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6021326. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    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 DURING THE SECOND DAY OF INFUSION A NURSE FOUND PRN SEPARATION ON A BD INTIMA II¿ IV CATHETER 24G X 0.75 IN. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774887 BD INTIMA II¿ IV CATHETER 24G X 0.75 IN. INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 6021326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other