BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFINE PENTIPS

    MDR report key: 3738416 · Received April 4, 2014

    Report

    Report Number
    MW5035579
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    OWNE MUMFORD USA INC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN WAS RECAPPING NEEDLE PER MANUFACTURERS INSTRUCTIONS AND NEEDLE PIERCED THE COVER STICKING THE RN IN THE FINGER. DATES OF USE: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205502 UNIFINE PENTIPS NONE FMI OWNE MUMFORD USA INC 2018-02 1302740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other