BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE ¿ IV CATHETER WINGED

    MDR report key: 7059416 · Received November 27, 2017

    Report

    Report Number
    8041187-2017-00220
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 2, 2017
    Report Date
    December 11, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903813125
    PMA / PMN Number
    K984059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO WAS RETURNED FOR INVESTIGATION. FM WAS OBSERVED IN THE RETURNED PHOTO. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7080439. THE NONCONFORMANCE CANNOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT WILL BE REOPENED IF THE SAMPLE IS RETURNED FOR INVESTIGATION. INVESTIGATION CONCLUSION: FM WAS OBSERVED IN THE RETURNED PHOTO. ROOT CAUSE DESCRIPTION: 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 A NURSE FOUND FOREIGN MATTER INSIDE A BD INSYTE ¿ IV CATHETER WINGED WHEN HE/SHE OPENED THE UNIT PACKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841442 BD INSYTE ¿ IV CATHETER WINGED INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7080439 30382903813125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other