BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ IV CATHETER

    MDR report key: 7366553 · Received March 23, 2018

    Report

    Report Number
    8041187-2018-00076
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 20, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7020251. THE ROOT CAUSE CANNOT BE DETERMINED AS NO SAMPLES WERE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER, DESCRIBED AS A ¿BLACK SMEAR¿, WAS SEEN ON THE SURFACE OF A BD INSYTE¿ IV CATHETER BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210898 BD INSYTE¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7020251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other