BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVOFINE 32G 6 MM

    MDR report key: 3833437 · Received May 21, 2014

    Report

    Report Number
    9681821-2014-00023
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 21, 2014
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    K090111
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE WAS BROKEN ON LATERAL THIGH NEAR THE HIP WHEN INJECTION [NEEDLE ISSUE] REDNESS AT THE INJECTION SITE IN THE BEGINNING [INJECTION SITE ERYTHEMA]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEATH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE REPORTED BY A CONSUMER FROM (B)(6), CONCERNS A (B)(6)-YEAR-OLD MALE PT WHO WAS USING NOVOFINE 32G 6 MM (NEEDLE) FOR AN UNK INDICATION AND REPORTED "NEEDLE WAS BROKEN ON LATERAL THIGH NEAR THE HIP WHEN INJECTION" BEGINNING ON (B)(6) 2014 AND "REDNESS AT THE INJECTION SITE IN THE BEGINNING" BEGINNING ON AN UNK DATE. PT HEIGHT: 172 CM. MEDICAL HISTORY INCLUDES HYPERTENSION. PT HAD NO FAMILY HISTORY, NO HISTORY OF ALLERGY AND ALCOHOL ABUSE. THE PT HAD REPORTEDLY BEEN USING NOVOFINE 32G 6 MM NEEDLE FROM AN UNK DATE. ON (B)(6) 2014, IN THE MORNING THE PT WAS INJECTED WITH NOVOFINE 32G NEEDLE (BATCH NO: UNK) AND NEEDLE BROKE IN THE LATERAL PART OF THIGH NEAR THE HIP DURING INJECTION. THE PT REPORTED THAT IT WAS DIFFICULT TO PULL UP THE NEEDLE, AND THE NEEDLE BROKE WHILE PULLING HARD. THE PT CHANGED THE NEEDLE EVERY FIVE DAYS. THE PT REPORTED THAT HIS DOCTOR INFORMED HIM THAT IT WAS UNNECESSARY AND TROUBLESOME TO REMOVE THE NEEDLE SINCE IT WAS SMALL AND THE PT WAS ALSO NOT WILLING TO HAVE A SURGERY. NO TESTS WERE PERFORMED. ON AN UNK DATE AT THE BEGINNING OF USAGE OF NOVOFINE 32G NEEDLE, PT ALSO EXPERIENCED REDNESS AT THE INJECTION SITE AND RECOVERED WITHOUT ANY TREATMENT. IT WAS REPORTED THAT PT CONTINUED TO USE NOVOFINE 32G NEEDLE. THE BATCH NUMBER IS UNK. IT IS UNK IF THE SUSPECTED PRODUCT STORED ACCORDING TO RECOMMENDATIONS. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS REPORTED AS NO CHANGE. OUTCOME OF THE EVENT "NEEDLE WAS BROKEN IN LATERAL THIGH NEAR THE HIP WHEN INJECTION" WAS NOT REPORTED. OUTCOME OF THE EVENT "REDNESS AT THE INJECTION SITE IN THE BEGINNING" WAS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301750 NVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other PROTAMINE SUSPENSION)| HUMALOG MIX25 (INSULIN LISPRO, INSULIN LISPRO