BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6 MM

    MDR report key: 9298252 · Received November 8, 2019

    Report

    Report Number
    9681821-2019-00075
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    October 14, 2019
    Report Date
    October 17, 2019
    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

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATION RESULTS: NAME: NOVOFINE® 32G ETW TIP 0.23/0.25*6MM. BATCH NUMBER: 19A02L. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. MICROSCOPIC EXAMINATION WAS PERFORMED OF NOVOFINE 32G 6MM NEEDLE. NEEDLE POINTS ON PATIENT NEEDLES EXAMINED VISUALLY FOR DEFECTS. NEEDLES TESTED FOR SILICONE ON PATIENT NEEDLE. AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. DURING INVESTIGATION IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE SAMPLE OF THE BATCH IN QUESTION. SINCE LAST SUBMISSION, THE FOLLOWING WAS UPDATED: -INVESTIGATION REPORTS UPDATED. -DEVICE CODES UPDATED. -MANUFACTURING COMMENT UPDATED. -NARRATIVE UPDATED ACCORDINGLY. MANUFACTURER COMMENT: 26-NOV-2019: AS THE DEVICE (NOVOFINE 32G 6 MM) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION AND ONLY VERY LIMITED INFORMATION REGARDING THE HANDLING OF SUSPECTED DEVICE IS AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT-CAUSE OF THE EXPERIENCED ADVERSE EVENT AND THUS FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN ARGUS CASE 691790. H3 CONTINUED: EVALUATION SUMMARY INVESTIGATION RESULTS: NAME: NOVOFINE® 32G ETW TIP 0.23/0.25*6MM. BATCH NUMBER: 19A02L. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. MICROSCOPIC EXAMINATION WAS PERFORMED OF NOVOFINE 32G 6MM NEEDLE. NEEDLE POINTS ON PATIENT NEEDLES EXAMINED VISUALLY FOR DEFECTS. NEEDLES TESTED FOR SILICONE ON PATIENT NEEDLE. AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. DURING INVESTIGATION IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE SAMPLE OF THE BATCH IN QUESTION.

    Description of Event or Problem · 1

    INJECTION SITE REDNESS [INJECTION SITE ERYTHEMA], INJECTION SITE SWELLING [INJECTION SITE SWELLING]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITY CASE RECEIVED VIA (B)(6) WAS REPORTED BY A HEALTH CARE PROFESSIONAL AS "INJECTION SITE REDNESS(INJECTION SITE REDNESS)" BEGINNING ON (B)(6) 2019, "INJECTION SITE SWELLING(INJECTION SITE SWELLING)" BEGINNING ON (B)(6) 2019, AND CONCERNED A (B)(6)-YEAR-OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOFINE 32G 6 MM (NEEDLE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", PATIENT HEIGHT, WEIGHT, BODY MASS INDEX WERE NOT REPORTED. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT PRODUCTS INCLUDED - NOVOMIX 30(INSULIN ASPART) SUSPENSION FOR INJECTION, 100 U/ML. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED IN THE HOSPITAL AND USED THE NOVOFINE 32G(6MM) NEEDLE. AFTER 24 HOURS OF INJECTION, ON (B)(6) 2019, THE PATIENT HAD EXPERIENCED INJECTION SITE SKIN REDNESS AND SWELLING. THE PATIENT DID NOT FEEL OF HOT NOR ITCHING. AFTER DISCONTINUING THE NEEDLE, THE SYMPTOMS DISAPPEARED A DAY LATER. BATCH NUMBERS: NOVOFINE 32G 6 MM: 19A02L. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS REPORTED AS PRODUCT DISCONTINUED DUE TO ADVERSE EVENT (AE). THE OUTCOME FOR THE EVENT "INJECTION SITE REDNESS(INJECTION SITE REDNESS)" WAS RECOVERED. THE OUTCOME FOR THE EVENT "INJECTION SITE SWELLING(INJECTION SITE SWELLING)" WAS RECOVERED. REFERENCES INCLUDED: REFERENCE TYPE: E2B REPORT DUPLICATE, REFERENCE ID#: (B)(4), REFERENCE NOTES: (B)(6). NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094634 NOVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S N/A 19A02L

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other NOVOMIX 30 (INSULIN ASPART)