BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIPS 31G X 8MM

    MDR report key: 9507180 · Received December 20, 2019

    Report

    Report Number
    8021764-2019-00016
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    August 25, 2020
    Manufacturer
    OWEN MUMFORD LIMITED
    Product Code
    FMI
    UDI-DI
    00384703530010
    PMA / PMN Number
    K152339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIRD PARTY MANUFACTURER INVESTIGATED SAMPLE PROVIDED BY PATIENT UNDER MAGNIFICATION. THE DEVICE SHOWED EVIDENCE OF REUSE, WITH FOLDING OF THE GLUE AND CANNULA, WHICH INDICATED THE NEEDLE BROKE DUE TO MISUSE. PATIENT ADMITTED REUSING NEEDLE MULTIPLE TIMES BEFORE THE BREAK. REUSE OF A NEEDLE WILL CAUSE IT TO BREAK. INVESTIGATION REPORTS ATTACHED. ATTACHMENT: [GBC-19-05894 - E53-4460.PDF, SR_1_1405405338_OM_UPDATE.PDF].

    Additional Manufacturer Narrative · 1

    PATIENT HAS RETURNED PENTIP THAT SHE USED BUT HAS NOT YET RETURNED THE MEDICAL QUESTIONNAIRE WITH DETAILS. THE PATIENT ADMITS REUSING HER PEN NEEDLES 2-3 TIMES PER INJECTION BEFORE CHANGING PEN NEEDLES. USED PENTIP HUB (MINUS THE NEEDLE) HAS BEEN RETURNED TO OUR MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO LET US KNOW THAT SHE HAD GIVEN HERSELF AN INJECTION AND WHEN SHE WENT TO REMOVE THE NEEDLE FROM HER SKIN, THE NEEDLE REMAINED IN HER SKIN. SHE WENT TO THE EMERGENCY ROOM WHERE THEY DID A SONOGRAM AND LOCATED THE NEEDLE, HOWEVER, WOULD NOT ATTEMPT TO REMOVE THE NEEDLE. THE ER ADVISED HER TO WAIT AND SEE IF IT EXPELLED ITSELF BECAUSE GOING TO REMOVE IT SURGICALLY WOULD CAUSE MORE DAMAGE TO HER. THE PATIENT ADMITTED TO USING HER PEN NEEDLES 2-3 TIMES BEFORE CHANGING THE NEEDLE, IN SPITE OF INSTRUCTIONS TO USE THE NEEDLE ONLY ONE TIME. SHE WAS INSTRUCTED AGAIN TO FOLLOW THE INSTRUCTIONS, TO USE THE PEN NEEDLES ONE TIME AND DISCARD IN A SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295872 UNIFINE PENTIPS 31G X 8MM PEN NEEDLES FMI OWEN MUMFORD LIMITED AN 3530 1703722.U038 00384703530010

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other