BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 3902202 · Received June 23, 2014

    Report

    Report Number
    2243072-2014-00135
    Event Type
    Injury
    Date Received
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: RESULTS: THE CUSTOMER HAS RETAINED THE SAMPLE INVOLVED, HOWEVER, THEY WILL NOT RELEASE THE SAMPLE FOR INVESTIGATION. CONCLUSIONS: WITHOUT A SAMPLE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REALIZED THAT AFTER INSERTING THE CATHETER INTO THE VEIN OF THE PATIENT, THE CATHETER DIDN'T REFLUX AS IT SHOULD. THE PROCEDURE WAS NOT PERFORMING NORMALLY. THE NURSE TRIED TO REMOVE THE CATHETER WITH THE NEEDLE BUT SHE DETECTED THE WHOLE CATHETER WASN'T WITHDRAWN, AND THAT PART OF THE CATHETER REMAINED IN THE PATIENT. A VASCULAR SURGERY SPECIALIST PROCEEDED TO OPERATE AND WITHDRAW THE PORTION OF TUBING LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366110 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FMI BECTON DICKINSON 3340932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention