BEUDAMED
    FDA Adverse Event Summary report: N

    NOVOFINE 8MM (30G) (NEEDLE) NA

    MDR report key: 1911554 · Received November 24, 2010

    Report

    Report Number
    9681821-2010-00039
    Date Received
    November 24, 2010
    Report Date
    October 28, 2010
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE BROKE INTO THE SKIN [NEEDLE ISSUE]. NEEDLE REMAINED IN HIS THIGH AND PRESENTS WITH HEMATOMA ON THE THIGH [INJECTION SITE HEMATOMA]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS IIA. THIS SPONTANEOUS REPORT WAS RECEIVED FROM (B)(6) AND REPORTED BY A DIABETES NURSE SPECIALIST AS "NEEDLE REMAINED IN HIS THIGH AND PRESENTS WITH HEMATOMA ON THE THIGH" AND "NEEDLE BROKE INTO THE SKIN". IT CONCERNS A (B)(6), MALE, TREATED WITH NOVOFINE 8MM 30G (NEEDLE) SINCE (B)(6) 2010 AND ONGOING FOR "TYPE 2 DIABETES MELLITUS". PATIENT'S HEIGHT: 170 CENTIMETERS. MEDICAL HISTORY INCLUDES TYPE 2 DIABETES SINCE 2002, PULMONARY PROBLEMS, MULTIPLE ALLERGIES AND OSTEOPOROSIS. ON AN UNSPECIFIED DATE WHEN THE PT WAS HOSPITALIZED DUE TO PULMONARY PROBLEMS (NOT IN RELATION TO THE REPORTED EVENTS), HE EXPERIENCED THAT THE NEEDLE BROKE WHILE INJECTION WAS PERFORMED. THE PT INJECTED CORRECTLY INTO SKIN FOLD, BUT WHEN HE REMOVED THE NEEDLE HE FELT A SLIGHT PINCH AND AFTER HAVING DROPPED THE CUTANEOUS FOLD HE INTENDED TO PUT THE CAP BACK ON THE NEEDLE HE NOTICED THAT THE NEEDLE WAS NOT PRESENT. AS A CONSEQUENCE THE PT PRESENTED WITH HAEMATOMA AT THE INJECTION SITE AND THE NEEDLE HURTS UNDER MOVEMENT. THE PT UNDERWENT AN X-RAY EXAMINATION OF THE THIGH AND THE NEEDLE WAS LOCATED. AN ULTRASOUND WAS ALSO PERFORMED AND A DOCTOR TRIED TO EXTRACT THE NEEDLE WITH A MAGNETIC NEEDLE, BUT WITHOUT SUCCESS. THE PT IS A TRAINED USER OF NOVOFINE NEEDLES. HE PERFORMS AIR SHOTS PRIOR TO EACH INJECTION. A FUNCTION CHECK WAS PERFORMED AND THE DEVICE PASSED THE TEST. THE PT INJECTS NOVORAPID (RAPID ACTING INSULIN ASPART) 3 TIMES DAILY AND CHANGES THE NEEDLE ONCE DAILY. THE NEEDLE WAS STORED ACCORDING TO RECOMMENDATIONS. THE PT HAS NEVER BEFORE EXPERIENCED SUCH EVENTS WHILE USING NOVOFINE NEEDLES. THE REMAINS OF THE NEEDLE WAS RETURNED FOR INVESTIGATION. THE OUTCOME WAS REPORTED AS "UNKNOWN". REPORTER COMMENT: COMMENT BY THE REPORTER: THE PT'S EVOLUTION WILL LEAD TO EITHER FIBROSIS DUE TO THE FOREIGN BODY OR TO A REJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 8MM (30G) (NEEDLE) NA NEEDLE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA 09B17Z

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other NOVORAPID (INSULIN ASPART) SOLUTION FOR INJECTION,| 100 U/ML| LANTUS/(B)(4)/(INSULIN GLARGINE)