BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIP PLUS

    MDR report key: 4438678 · Received January 19, 2015

    Report

    Report Number
    1058602-2015-00002
    Event Type
    Injury
    Date Received
    January 19, 2015
    Date of Event
    December 26, 2014
    Report Date
    January 19, 2015
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMI
    PMA / PMN Number
    K973899
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LABELING INDICATES UNIFINE PENTIP PLUS IS FOR PERSONAL USE AND NOT FOR CLINICAL USE.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO HAPPEN ON (B)(6) 2014, THE EVENT WAS REPORTED TO US ON (B)(6) 2014. A MEDICAL QUESTIONAIRE WAS SENT FOR COMPLETION AND RETURN AND AFTER MULTIPLE ATTEMPTS TO RETRIEVE, THE MEDICAL QUESTIONAIRE WAS RECEIVED BY US ON (B)(6) 2015. THE MEDICAL QUESTIONAIRE STATES THAT AN EXAM AND BLOOD WORK WAS PERFORMED AND NO OTHER DETAILS ARE GIVEN. NURSE FOR ASSISTED LIVING FACILITY REPLACED CAP BACK ONTO DEVICE AFTER PERFORMING INJECTION ON PT. DEVICE NEEDLE PENETRATED THROUGH THE SIDE OF THE CAP EXPOSING THE NEEDLE AND THE NURSE DID NOT REALIZE THIS AND STUCK HER FINGER ON THE EXPOSED NEEDLE. THE DEVICE WAS DISPOSED OF IN THE SHARPS CONTAINER AND THE NURSE WAS SENT TO THE ER FOR TESTS. MFR REF # 8021764-2015-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43927 UNIFINE PENTIP PLUS PEN NEEDLE FMI OWEN MUMFORD LTD AN 3830 12P4003

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other