BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ARTERIAL CANNULA

    MDR report key: 5836689 · Received August 1, 2016

    Report

    Report Number
    2243072-2016-00023
    Event Type
    Injury
    Date Received
    August 1, 2016
    Date of Event
    July 6, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 204038. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. 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

    BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED AS THE MANUFACTURING SITE OF THIS DEVICE; THE ACTUAL MANUFACTURING SITE (B)(6) IS AN OEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUSPECT DEVICE WAS DISCOVERED TO BE "FRACTURED" WHEN THE DRESSING WAS REMOVED IN THE RECOVERY ROOM. NO MEDICAL INTERVENTION WAS RENDERED AT THAT TIME, AND NONE HAS BEEN REPORTED; HOWEVER, "THE PATIENT REQUIRES AN APPOINTMENT IN ANOTHER TRUST (QMC) FOR PLAN FOR REMOVAL AS UNABLE TO UNDERTAKE THE PROCEDURE AT THIS TRUST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489605 BD¿ARTERIAL CANNULA INTRAVENOUS INFUSION DEVICE FOZ BECTON DICKINSON 204038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention