BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIP PLUS

    MDR report key: 6623082 · Received June 8, 2017

    Report

    Report Number
    8021764-2017-00002
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    April 24, 2017
    Report Date
    June 5, 2017
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMI
    PMA / PMN Number
    K152339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DEFECTIVE IF USED IN ACCORDANCE WITH IFU AND THE NEEDLE IS PLACED INTO THE CORRECT CHAMBER IN A STRAIGHT TRAJECTORY. THE UNIFINE PENTIP PLUS DEVICE IS NOT RECOMMENDED FOR CLINICAL USE WHICH IS STATED IN THE DIRECTIONS. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    OWEN MUMFORD (B)(4) RECEIVED NOTIFICATION FROM THE ANSM RELATED TO AN INCIDENT WHICH OCCURRED (B)(6) 2017 WITH UNIFINE PENTIP PLUS 5MM. THE COMPLAINT WAS NOT REPORTED TO OM (B)(4) PRIOR TO THE ANSM NOTIFICATION AND HAS JUST BEEN REPORTED TO OMI USA FOR SUBMISSION. THE COMPLAINT DETAILED AN INJURY TO A NURSE AFTER INJECTION ON A PATIENT. THE USED PENTIP WAS INSERTED INTO THE REMOVER HUB BUT THE NEEDLE BENT AGAINST THE WALL AND PASSED THROUGH THE WALL OF THE REMOVER HUB. OM (B)(4) CONTACTED THE NURSE MANAGER OF THE HOSPITAL TO STATE THAT THESE DEVICES ARE NOT FOR CLINICAL USE. THE DEVICE HAS BEEN DISPOSED OF AND THE NURSE IS SAFE WITH NO SEREOLOGY CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407295 UNIFINE PENTIP PLUS PEN NEEDLE FMI OWEN MUMFORD LTD AN 3629 16X8002-014662

    Patients

    Seq Age Sex Outcome Treatment
    1 Other