BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE 32

    MDR report key: 2439535 · Received January 31, 2012

    Report

    Report Number
    9681821-2012-00003
    Event Type
    Other
    Date Received
    January 31, 2012
    Date of Event
    January 1, 2011
    Report Date
    January 5, 2012
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K062500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE BREAK IN SKIN AND NEEDED SURGERY TO REMOVE IT [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: THIS SPONTANEOUS CASE FROM THE UNIT STATES WAS REPORTED BY A CONSUMER AS "NEEDLE BROKE OFF IN THE SKIN AND NEEDED SURGERY TO REMOVE IT" AND CONCERNS A (B)(6) FEMALE PT USING NOVO FINE 32 NEEDLE FOR UNSPECIFIED PERIOD OF TIME DUE TO TYPE 2 DIABETES MELLITUS. PT'S HEIGHT: (B)(6). MEDICAL HISTORY INCLUDED TYPE 2 DIABETES MELLITUS. A PT REPORTED THAT ON ONE PARTICULAR OCCASION, SEVERAL MONTHS EARLIER, SHE NOTICED THAT A NEEDLE BROKE OFF IN HER ABDOMEN FOLLOWING AN INJECTION. SHE STATED THAT SHE REPLACED THE NEEDLE JUST PRIOR TO THE INJECTION BUT THAT SHE USUALLY LEAVES USED NEEDLES ATTACHED TO HER FLEXPEN IN BETWEEN INJECTION. SHE REPORTED THAT APPROXIMATELY TWO DAYS AFTER THE INCIDENT THE NEEDLE WAS REMOVED VIA A SURGICAL PROCEDURE PERFORMED IN HER PHYSICIAN'S OFFICE. IN ADDITION, THE PT REPORTED THAT SHE TYPICALLY "PERFORMED AIR SHOTS PRIOR TO ATTACHING A NEEDLE TO HER FLEXPEN." THE PT REPORTED THAT SHE WAS NOT CERTAIN OF THE BRAND AND SIZE OF THE NEEDLES SHE USED AT THE TIME OF THE EVENT. THE EVENT OF "INJURY ASSOCIATED WITH DEVICE" WAS REPORTED AS "RECOVERED" ON AN UNK DATE. NOTE: NOVOFINE 32 WAS CHOSEN AS SUSPECTED PRODUCT SINCE IT IS THE MOST WIDELY DISTRIBUTED NEEDLE BY NOVO NORDISK IN THE UNITED STATES. THE PT COULD NOT IDENTIFY EXACT BRAND OF NEEDLE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 32 NEEDLE FMI NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LEVEMIR FLEXPEN (INSULIN DETEMIR) SOLUTION FOR| INJECTION, .0024 MOL/L ONGOING.