BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE 31

    MDR report key: 1028452 · Received April 10, 2008

    Report

    Report Number
    9681821-2008-00020
    Event Type
    Other
    Date Received
    April 10, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 14, 2008
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K002403
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BROKE OFF TWO NEEDLES IN SKIN (STOMACH), WHICH HAD TO GET REMOVED [MEDICAL DEVICE COMPLICATION]. CASE DESCRIPTION: MEDICAL DEVICE INFORMATION: THIS SPONTANEOUS REPORT, REPORTED BY A CUSTOMER, REPORTED AS "BROKE OFF TWO NEEDLES IN SKIN (STOMACH), WHICH HAD TO GET REMOVED", CONCERNS A MALE PT TREATED WITH NOVOFINE 31 GAUGE DISPOSABLE NEEDLES FROM 2007 TO ONGOING AND NOVOLOG (RAPID ACTING INSULIN AS PART) FLEXPEN FROM 2007 TO ONGOING FOR "INSULIN-REQUIRING TYPE II DIABETES MELLITUS". MEDICAL HISTORY INCLUDED OBESITY (WEIGHT UNK), SLEEP APNEA, AND HYPERTENSION. IN 2008, TWO NOVOFINE 31 GAUGE DISPOSABLE NEEDLES BROKE OFF IN THE MAN'S SKIN (STOMACH). THE PT REPORTED THAT HIS NOVOLOG FLEXPENS WERE NOT WORKING PROPERLY AND THE TIP OF THE NEEDLES BROKE OFF. HE STATED THAT THE NEEDLES WERE NOT DEEP IN HIS SKIN AND HE COULD SEE THE EDGE OF THE NEEDLES. THE PT STATED THAT HE WAS UNABLE TO REMOVE THE NEEDLES BY HIMSELF; THEREFORE, HE WENT TO THE EMERGENCY ROOM. BOTH NEEDLES WERE REMOVED BY THE EMERGENCY ROOM PHYSICIAN WITH TWEEZERS. NO OTHER TREATMENT WAS RECEIVED. THE PT REPORTED THAT NO X-RAY WAS REQUIRED. THE EVENT RESOLVED THAT SAME DAY AND HE WAS DISCHARGED FROM THE EMERGENCY ROOM. THE OVERALL OUTCOME WAS REPORTED AS RECOVERED IN 2008 (EXACT DATE UNK). REPORTER COMMENT: THE PT STATED THAT HE BLAMES THE NOVOLOG FLEX PENS AS THE CAUSE FOR THE BROKEN NEEDLES. COMMENT: COMPANY COMMENT: BASED ON THE RECEIVED INFO THERE IS NO CAUSE AND EFFECT RELATIONSHIP BETWEEN NOVOLOG AND THE REPORTED EVENT: THIS IS AN INITIAL REPORT AND FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 31 NEEDLE FMI NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention LOTREL 01289101 (AMLODIPINE| HYDROCHLORIDE) UNK TO ONGOING| PROVIGIL (MODAFINIL) UNK TO ONGOING| LANTUS (INSULIN GLARGINE) UNK TO ONGOING