BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6 MM

    MDR report key: 17832201 · Received September 28, 2023

    Report

    Report Number
    9681821-2023-00135
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 1, 2023
    Report Date
    September 12, 2023
    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

    CASE DESCRIPTION: INVESTIGATION RESULT: NAME: NOVOFINE 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 21D06Y THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT(S) FOR FURTHER INVESTIGATIONS. SINCE LAST SUBMISSION FOLLOWING HAS BEEN UPDATED - INV RESULTS WERE UPDATED. - ANNEX BCDG CODES WERE UPDATED. - NARRATIVE WAS UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 29-NOV-2023: THE RELEVANT INFORMATION REGARDING NEEDLE USAGE TRAINING, NEEDLE REUSAGE, USER OF THE DEVICE AT THE TIME OF INCIDENT, BATCH NUMBER OF DEFECTIVE NEEDLE ARE UNAVAILABLE FOR COMPLETE ASSESSMENT. THE SUSPECTED DEVICE (NOVOFINE 32G NEEDLE) HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND IN THE REFERENCE SAMPLE ANALYSIS. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. WITH THE AVAILABLE LIMITED INFORMATION REGARDING THE HANDLING OF THE SUSPECTED DEVICE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT CAUSE IN RELATION TO FUNCTIONALITY OF NOVOFINE 32G NEEDLE. H3 CONTINUED: EVALUATION SUMMARY NAME: NOVOFINE 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 21D06Y THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT(S) FOR FURTHER INVESTIGATIONS.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS [INJECTION SITE ERYTHEMA]. THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS [INJECTION SITE SWELLING]. THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS [INJECTION SITE PRURITUS]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITY CASE RECEIVED VIA NMPA (NATIONAL MEDICAL PRODUCTS ADMINISTRATION), FROM CHINA WAS REPORTED BY A HEALTH CARE PROFESSIONAL NOS AS "THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS(INJECTION SITE REDNESS)" BEGINNING ON (B)(6) 2023, "THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS(INJECTION SITE SWELLING)" BEGINNING ON (B)(6) 2023, "THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS(INJECTION SITE PRURITUS)" BEGINNING ON (B)(6) 2023, AND CONCERNED A 61 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOFINE 32G 6 MM (NEEDLE) FROM (B)(6)2023 FOR "DIABETES MELLITUS", INSULIN (INSULIN) (DOSE, FREQUENCY & ROUTE USED-UNK) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX (BMI) WAS NOT REPORTED. CURRENT CONDITION: DIABETES MELLITUS (TYPE AND DURATION WAS REPORTED). ON (B)(6) 2023, THE PATIENT EXPERIENCED INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS, AFTER USING THIS PRODUCT FOR INJECTION AND THEN THE PATIENT WENT TO THE HOSPITAL FOR ANTI-ALLERGIC TREATMENT. ON THE SECOND DAY AFTER RECEIVING ANTI-ALLERGIC TREATMENT, THE REPORTED ADVERSE EVENT "THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS" HAD RECOVERED. THE SPECIFIC DATE OF RECOVERY WAS UNKNOWN. BATCH NUMBERS: NOVOFINE 32G 6 MM: 21D06Y. BATCH NUMBER OF INSULIN WAS NOT REPORTED. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS NOT REPORTED. ACTION TAKEN TO INSULIN WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS(INJECTION SITE REDNESS)" WAS RECOVERED. THE OUTCOME FOR THE EVENT "THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS(INJECTION SITE SWELLING)" WAS RECOVERED. THE OUTCOME FOR THE EVENT "THE INJECTION SITE HAD REDNESS AND SWELLING, ACCOMPANIED WITH PRURITUS(INJECTION SITE PRURITUS)" WAS RECOVERED. NO FURTHER INFORMATION AVAILABLE. REFERENCES INCLUDED: REFERENCE TYPE: E2B AUTHORITY NUMBER. REFERENCE ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982808 NOVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S N/A 21D06Y

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other