BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6 MM

    MDR report key: 15860622 · Received November 24, 2022

    Report

    Report Number
    9681821-2022-00091
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    October 21, 2022
    Report Date
    October 31, 2022
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    K090111
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) THE NOVOFINE WAS BROKEN [NEEDLE ISSUE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITY CASE RECEIVED VIA NMPA (NATIONAL MEDICAL PRODUCTS ADMINISTRATION), CHN " WAS REPORTED BY A HEALTH CARE PROFESSIONAL NOS AS "THE NOVOFINE WAS BROKEN(NEEDLE BROKEN)" BEGINNING ON (B)(6) 2022, AND CONCERNED A 43 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOFINE 32G 6 MM (NEEDLE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX NOT REPORTED. DOSAGE REGIMENS: NOVOFINE 32G 6 MM: CURRENT CONDITION: DIABETES MELLITUS. CONCOMITANT PRODUCTS INCLUDED - INSULIN. IT WAS REPORTED THAT THE PATIENT CAME TO OUR HOSPITAL FOR TREATMENT DUE TO DIABETES MELLITUS. THE DOCTOR PRESCRIBED INSULIN AND NOVOFINE AFTER DIAGNOSIS. ON (B)(6) 2022 DURING THE USE OF NOVOFINE NEEDLE, IT WAS FOUND THAT THE NOVOFINE WAS BROKEN WHICH MAY CAUSE SERIOUS CONSEQUENCES IN HUMAN BODY. BATCH NUMBERS: NOVOFINE 32G 6 MM: 20K11Y. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE NOVOFINE WAS BROKEN(NEEDLE BROKEN)" WAS NOT REPORTED. REFERENCES INCLUDED: REFERENCE TYPE: E2B AUTHORITY NUMBER; REFERENCE ID#: (B)(4); REFERENCE NOTES: NMPA. NO FURTHER INFORMATION AVAILABLE. PRELIMINARY MANUFACTURER'S COMMENT: 09-NOV-2022: THE SUSPECTED DEVICE NOVOFINE 32G 6MM NEEDLE OR NEEDLES FROM SAME BATCH /BOX HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. RELEVANT INFORMATION ON USER OF DEVICE AT THE TIME OF EVENT, DEVICE HANDLING TRAINING FROM HEALTH CARE PROFESSIONAL AND IMPROPER USE OR STORAGE ARE UNAVAILABLE FOR COMPLETE ASSESSMENT. NO CONCLUSION IS REACHED.

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATION RESULT NOVOFINE® 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 20K11Y THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION, THIS CASE HAS BEEN UPDATED WITH THE FOLLOWING INVESTIGATION RESULT UPDATED IMDRF ANNEX B, C, D, AND G CODES UPDATED. NARRATIVE UPDATED ACCORDINGLY. PRELIMINARY MANUFACTURER'S COMMENT: (B)(6) 2022: THE SUSPECTED DEVICE NOVOFINE 32G 6MM NEEDLE OR NEEDLES FROM SAME BATCH /BOX HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. RELEVANT INFORMATION ON USER OF DEVICE AT THE TIME OF EVENT, DEVICE HANDLING TRAINING FROM HEALTH CARE PROFESSIONAL AND IMPROPER USE OR STORAGE ARE UNAVAILABLE FOR COMPLETE ASSESSMENT. NO CONCLUSION IS REACHED. H3 CONTINUED: EVALUATION SUMMARY NOVOFINE® 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 20K11Y THE PRODUCT WAS NOT RETURNED FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731956 NOVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S N/A 185189

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other INSULIN (INSULIN)