BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE 6MM (31G) (NEEDLE) NA

    MDR report key: 2021837 · Received March 7, 2011

    Report

    Report Number
    9681821-2011-00010
    Event Type
    Other
    Date Received
    March 7, 2011
    Report Date
    February 8, 2011
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE STUCK IN HER ABDOMEN [NEEDLE ISSUE]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. CLASS IIA. THIS SPONTANEOUS REPORT REC'D FROM (B)(6) AND REPORTED BY A HEALTH CARE PROFESSIONAL NOS AS "NEEDLE STUCK IN HER ABDOMEN". IT CONCERNS A FEMALE PT USING NOVOFINE 6MM (31G) (NEEDLE) FROM AN UNK DATE AND ONGOING FOR "DEVICE THERAPY". PATIENT'S HEIGHT: NOT REPORTED. MEDICAL HISTORY: THE PT WAS OBESE AND WAS UNDER CHEMOTHERAPY. ABOUT (B)(6) AGO, A PIECE OF A BROKEN NOVOFINE 6MM NEEDLE STUCK IN THE PATIENT'S ABDOMEN. THIS NEEDLE WAS NEVER REMOVED AND NOT REPORTED. THE PT WAS NOT ON CHEMOTHERAPY AND NEEDED A MRI SCAN WHICH WAS NOT POSSIBLE BECAUSE OF THE BROKEN NEEDLE IN HER ABDOMEN. AFTER UNSPECIFIED INVESTIGATION, THE BROKEN NEEDLE WAS NOT FOUND AND SUBSEQUENTLY A MRI (MAGNET RESONANCE IMAGING) SCAN WAS PERFORMED (DATE AND RESULT WAS NOT REPORTED). THE OVERALL OUTCOME WAS "NOT REPORTED". NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 6MM (31G) (NEEDLE) NA NEEDLE FMI NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention