BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIFINE PENTIPS

    MDR report key: 2494066 · Received February 21, 2012

    Report

    Report Number
    8021764-2012-00002
    Event Type
    Other
    Date Received
    February 21, 2012
    Report Date
    February 20, 2012
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMI
    PMA / PMN Number
    K973899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PEN NEEDLE HAS BROKEN INSIDE THE STOMACH OF THE PATIENT (ARTSANA CODE (B)(4)). THE NEEDLE HAS BEEN REMOVED BY THE NURSE WITH A PAIR OF TWEEZERS. ARTSANA IS THE PRODUCER WHILE OWNE MUMFORD IS THE MANUFACTURER. ALL ARTSANA PEN NEEDLE ARE CONFORMED TO THE ISO 9626 "STAINLESS STEEL NEEDLE TUBING FOR MANUFACTURER OF MEDICAL DEVICES" WITH NORMAL SINGLE USE BENDING / BREAKING SHOULD NOT OCCUR. WE WILL PROCEED WITH ANALYSIS ON THE 86 PIECES OF PEN TIPS WE RECEIVED. NO OTHER RELATED COMPLAINTS WERE RAISED AGAINST THIS LOT.

    Description of Event or Problem · 1

    THE PEN NEEDLE HAS BROKEN INSIDE THE STOMACH OF THE PATIENT (ARTSANA CODE (B)(4)). THE NEEDLE HAS BEEN REMOVED BY THE NURSE WITH A PAIR OF TWEEZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFINE PENTIPS UNIFINE FMI OWEN MUMFORD LTD 1106739

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization