BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6 MM

    MDR report key: 12933397 · Received December 6, 2021

    Report

    Report Number
    9681821-2021-00085
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    September 30, 2021
    Report Date
    November 16, 2021
    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 RESULTS: NAME: NOVOFINE 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 20G04Y. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT(S) FOR FURTHER INVESTIGATIONS. BATCH NUMBERS: NOVOFINE 32G 6 MM: 20G04Y. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -INVESTIGATION RESULTS UPDATED. -RELEVANT FIELDS UPDATED IN EU/CA TAB. -ANNEX B,C,D,G CODES ADDED. -NARRATIVE UPDATED WITH RELEVANT INFORMATION. FINAL MANUFACTURER'S COMMENT: (B)(6) 2022: THE SUSPECTED DEVICE NOVOFINE 32G NEEDLE HAS NOT BEEN RETURNED TO NOVO NORDISK FOR INVESTIGATION. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. NO REFERENCE SAMPLE ANALYSIS PERFORMED. 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 NEEDLES. H3 CONTINUED: EVALUATION SUMMARY: NAME: NOVOFINE 32G ETW TIP 0.23/0.25 6MM, BATCH NUMBER: 20G04Y. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT(S) FOR FURTHER INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITY CASE RECEIVED VIA (B)(6) WAS REPORTED BY A HEALTH CARE PROFESSIONAL AS "REDNESS AT THE INJECTION SITE(INJECTION SITE REDNESS)" BEGINNING ON (B)(6) 2021, "SWELLING AT THE INJECTION SITE(INJECTION SITE SWELLING)" BEGINNING ON (B)(6) 2021, "PRURITUS AT THE INJECTION SITE(INJECTION SITE PRURITUS)" BEGINNING ON (B)(6)2021, "DEVICE FAILURE(DEVICE FAILURE)" BEGINNING ON (B)(6) 2021, AND CONCERNED A (B)(6) MALE PATIENT WHO WAS TREATED WITH NOVOFINE 32G 6 MM (NEEDLE) FROM (B)(6) 2021 FOR "DIABETES MELLITUS". THE PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX (BMI) WAS NOT REPORTED. CURRENT CONDITION: DIABETES MELLITUS (TYPE AND DURATION NOT REPORTED). CONCOMITANT PRODUCTS INCLUDED - INSULIN. ON (B)(6) 2021, THE PATIENT HAD TO INJECT INSULIN. AFTER USING NOVOFINE 32G 6 MM, THERE WERE REDNESS, SWELLING AND PRURITUS AT THE INJECTION SITE. AFTER 15 MINUTES, THE PATIENT CAME TO THE HOSPITAL FOR ANTI-ALLERGIC TREATMENT AND WAS RECOVERING. IT WAS REPORTED THAT THERE WAS A DEVICE FAILURE. BATCH NUMBERS: NOVOFINE 32G 6 MM: 20G04Y. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "REDNESS AT THE INJECTION SITE(INJECTION SITE REDNESS)" WAS RECOVERING/RESOLVING. THE OUTCOME FOR THE EVENT "SWELLING AT THE INJECTION SITE(INJECTION SITE SWELLING)" WAS RECOVERING/RESOLVING. THE OUTCOME FOR THE EVENT "PRURITUS AT THE INJECTION SITE(INJECTION SITE PRURITUS)" WAS RECOVERING/RESOLVING. THE OUTCOME FOR THE EVENT "DEVICE FAILURE(DEVICE FAILURE)" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830546 NOVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S N/A 20G04Y

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other INSULIN (INSULIN) SOLUTION FOR INJECTION.