BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-JECT

    MDR report key: 5376732 · Received January 19, 2016

    Report

    Report Number
    3004827015-2016-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    November 4, 2015
    Report Date
    January 19, 2016
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    FMI
    PMA / PMN Number
    K002992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BO-JECT NEEDLE BENT ON INSERTION AND WHEN THE CLINICIAN WENT TO PULL IT OUT, THE NEEDLE SEPARATED FROM THE HUB AND REMAINED IN THE PATIENT. THE NEEDLE WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY AND THE PATIENT DID NOT REQUIRE FURTHER TREATMENT OR CARE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36645 BO-JECT DHF NEEDLE FMI ALPINE BIOMED APS 9013S0422 1016/1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other