BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE

    MDR report key: 3072392 · Received April 19, 2013

    Report

    Report Number
    2243072-2013-00034
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER STATED THAT AFTER PLACING THE CATHETER ON UPPER ARM OF THE PATIENT, PATIENT TOOK OUT THE CATHETER BY HERSELF. CLINICIAN NOTICED CATHETER WAS CUT. THE CUT PORTION WAS NOT FOUND. CLINICIAN TOOK X-RAY BUT COULDN'T FIND THE REST OF THE PORTION ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168882 BD INSYTE 22G X 1.0IN FOZ BD 388423

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention