BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIPS

    MDR report key: 3503476 · Received November 6, 2013

    Report

    Report Number
    1058602-2013-00001
    Event Type
    Injury
    Date Received
    November 6, 2013
    Date of Event
    October 1, 2013
    Report Date
    November 6, 2013
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 NURSE FROM (B)(6) CALLED TO REPORT THAT AFTER HE INJECTED A PATIENT WITH HIS INSULIN AND WAS REMOVING THE PEN NEEDLE FROM THE PEN, THE NEEDLE CAME THROUGH THE OUTER COVERING AND WAS ACCIDENTALLY STUCK. THE PATIENT HE INJECTED WAS (B)(6). THE NURSE INFORMED US THAT THE PATIENT COMES IN EVERY DAY FOR HIS INJECTIONS; THE SUPPLIES ARE SENT BY THE (B)(4) ACCORDING TO HIS PRESCRIPTION. THE NURSE DID NOT INITIALLY SPECIFY THE DATE OF THE EVENT. FURTHER CONTACT WAS MADE TO GAIN MORE DETAILS AND AGAIN ASK FOR THE SAMPLE IF AVAILABLE AS WELL AS THE REMAINING PEN NEEDLES FOR EVALUATION AND ALSO THE RETURN OF THE MEDICAL QUESTIONNAIRE. A PICTURE OF THE NEEDLE THROUGH THE OUTER CONTAINER WAS SENT VIA EMAIL. SINCE THIS TIME, THERE HAVE BEEN MULTIPLE ATTEMPTS TO RETRIEVE THE SAMPLES AND QUESTIONNAIRE WITH NO AVAIL. AS OF THE DATE OF THIS REPORT, NOTHING HAS BEEN RECEIVED. PLEASE REFER MFR REPORT # 8021764-2013-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572767 UNIFINE PENTIPS PEN NEEDLES FMI OWEN MUMFORD LTD AN 3530 1212739

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other INSULIN