BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE, UNSPECIFIED

    MDR report key: 3834453 · Received May 9, 2014

    Report

    Report Number
    9681821-2014-00019
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REGISTERED NURSE REPORTED THAT ON (B)(6) 2014, SHE ADMINISTERED A DOSE OF NOVOLOG FLEXPEN WITH AN UNSPECIFIED NOVO NORDISK NEEDLE TO A (B)(6) PATIENT. THE NURSE THEN ATTEMPTED TO RECAP THE NEEDLE BUT STATED THAT THE NEEDLE WENT THROUGH THE PLASTIC AND SHE ACCIDENTALLY STUCK HERSELF WITH THE NEEDLE. SHE STATED THE NEEDLE DID NOT GET STUCK IN HER SKIN. AS A RESULT, THE NURSE WENT TO THE ER (EMERGENCY ROOM) THAT SAME NIGHT AND HAD BLOOD WORK DONE (RESULTS WERE PENDING). THE NURSE RECEIVED TREATMENT WITH ISENTRESS (RALTEGRAVIR POTASSIUM) AND TRUVADA (EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE) AS PROPHYLACTIC MEDICATIONS FOR SUSPECTED TRANSMISSION OF (B)(6). THE NURSE WAS RELEASED FROM THE ER THAT SAME NIGHT ON (B)(6) 2014. ACTION TAKEN WITH THE NOVO NORDISK NEEDLE WAS NOT APPLICABLE AS THE NURSE WAS NOT USING THE NEEDLE HERSELF. THE OUTCOME FOR THE EVENT OF "ACCIDENTALLY STUCK HERSELF WITH THE NEEDLE" WAS REPORTED AS RECOVERED ON (B)(6) 2014. THE OUTCOME FOR THE EVENT OF "SUSPECTED TRANSMISSION OF (B)(6)" WAS NOT REPORTED. REPORTER COMMENT: THE REGISTERED NURSE FELT THAT THE EVENTS WERE RELATED TO THE NOVO NORDISK NEEDLE. THE BATCH AND PRODUCT WERE NOT AVAILABLE. THE NURSE DECLINED TO PROVIDE HER HEALTH CARE PROVIDER'S INFO.

    Description of Event or Problem · 1

    ACCIDENTALLY STUCK HERSELF WITH THE NEEDLE [INJURY ASSOCIATED WITH DEVICE]. SUSPECTED TRANSMISSION OF (B)(6) [SUSPECTED TRANSMISSION OF AN INFECTIOUS AGENT VIA PRODUCT]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A NURSE (WHO WAS ALSO THE PT), AND CONCERNED A (B)(6)-YEAR OLD FEMALE PT WHO ACCIDENTALLY STUCK HERSELF WITH A NOVO NORDISK NEEDLE (TYPE AND GAUGE UNSPECIFIED) AND REPORTED "ACCIDENTALLY STUCK HERSELF WITH THE NEEDLE" AND "SUSPECTED TRANSMISSION OF (B)(6)" ALL BEGINNING ON (B)(6) 2014. PT'S HEIGHT: 158 CM. MEDICAL HISTORY INCLUDED HYPOTHYROIDISM AND ASTHMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281156 NEEDLE, UNSPECIFIED NEEDLE FMI NOVO NORDISK A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other SYNTHROID (LEVOTHYROXINE SODIUM)| SINGULAIR (MONTELUKAST SODIUM)