BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE (30G)

    MDR report key: 2893215 · Received December 21, 2012

    Report

    Report Number
    9681821-2012-00030
    Event Type
    Other
    Date Received
    December 21, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 11, 2012
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMF
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE BROKE OFF IN STOMACH [NEEDLE ISSUE]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES, WAS REPORTED BY A CONSUMER AS "NEEDLE BROKE OFF IN STOMACH" ON (B)(6) 2012. IT CONCERNS A (B)(6) YEAR-OLD MALE PATIENT TREATED WITH NOVOFINE 6MM (30G) NEEDLE FROM 2009 (EXACT DATE UNKNOWN), AND ONGOING DUE TO TYPE 2 DIABETES MELLITUS. PATIENT'S HEIGHT: (B)(6) CM. MEDICAL HISTORY INCLUDES TYPE 2 DIABETES MELLITUS FOR OVER 10 YEARS. ON THE MORNING OF (B)(6) 2012, THE PATIENT USED A NOVOFINE 30 NEEDLE TO ADMINISTER HIS INSULIN. AFTER HE INJECTED HIMSELF ON THE LEFT SIDE OF HIS ABDOMEN, THE NEEDLE BROKE OFF INTO THE INJECTION SITE. THE ENTIRE NEEDLE WAS LODGED IN HIS SKIN. THE PATIENT CALLED HIS PRIMARY CARE PHYSICIAN (PCP) FOR ADVICE. HIS PCP ADVISED HIM TO GO TO THE EMERGENCY ROOM (ER). THE PATIENT DROVE HIMSELF TO THE ER. THE PATIENT UNDERWENT AN X-RAY THAT CONFIRMED THAT THE NEEDLE WAS IN HIS SKIN. THE ER PHYSICIAN ATTEMPTED TO REACH THE NEEDLE BY MANUALLY PROBING THE INJECTION SITE. THIS WAS UNSUCCESSFUL SO THE PHYSICIAN MADE A SMALL INCISION IN THE PATIENT'S ABDOMEN AND REMOVED THE NEEDLE. THE AREA OF INCISION WAS CLOSED WITH ONE DISSOLVING STITCH AND BANDAGED. THE PATIENT WAS INSTRUCTED TO KEEP THE AREA DRY FOR TWO DAYS AND FOLLOW-UP WITH HIS PCP. THE PATIENT REPORTED THAT THIS WAS THE FIRST TIME THAT A NOVOFINE NEEDLE HAD BROKEN WHILE HE WAS USING IT. ACTION TAKEN TO NOVOFINE NEEDLE WAS NO CHANGE. THE OUTCOME OF "NEEDLE BROKE OFF IN STOMACH" WAS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE (30G) NEEDLE FMF NOVO NORDISK A/S NA 11J14X

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R