BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ARTERIAL CANNULA WITH FLOWSWITCH

    MDR report key: 3862971 · Received June 4, 2014

    Report

    Report Number
    2243072-2014-00123
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BD
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE WAS INSERTED WITHOUT ANY COMPLICATION IN THE OPERATING ROOM. THE PATIENT HAD A LARGE SPACE-OCCUPYING LESION THAT WAS GIVEN THE ARTERIAL LINE, LEFT FRONTAL PERIOPERATIVE. THE LINE WAS SCHEDULED TO BE REMOVED AT THE MEDICAL CARE WARD PRIOR TO THE TRANSFER TO THE LOW CARE WARD. THE NURSE REMOVED THE LINE AND EXPERIENCED SLIGHT RESISTANCE. DURING REMOVAL, THE CANNULA BROKE. THE CANNULA WAS LOCATED ECHOGRAPHICALLY IN THE LEFT ARTERIA RADIALIS. IT WAS NOT REACHABLE. THE VASCULAR SURGEON WAS CONSULTED AND THE CANNULA WAS REMOVED UNDER PLEXUS ANESTHESIA. THE PATIENT HAS SUFFERED NO FURTHER CONSEQUENCES AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326120 BD ARTERIAL CANNULA WITH FLOWSWITCH ARTERIAL CANNULA DQO BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention