BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6 MM

    MDR report key: 18381431 · Received December 22, 2023

    Report

    Report Number
    9681821-2023-00175
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    November 13, 2023
    Report Date
    November 24, 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: 21E04Y. THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING INFORMATION: -INVESTIGATION RESULTS UPDATED. -IMDRF CODES UPDATED. -MALFUNCTION UPDATED AS ''NO''. -IS NON REPORTABLE UPDATED AS ''NO''. -NARRATIVE UPDATED ACCORDINGLY. NO FURTHER INFORMATION AVAILABLE. FINAL MANUFACTURER'S COMMENT: AS OF 21-MAR-2024: THE SUSPECTED DEVICE NOVOFINE 32G 6 MM 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 NEEDLE. CONSIDERING THE NATURE OF EVENTS, ROUTE OF ADMINISTRATION BEING SUBCUTANEOUS, THE REPORTED INJECTION SITE REACTIONS COULD BE ATTRIBUTED INCORRECT PRODUCT HANDLING. H3 CONTINUED: EVALUATION SUMMARY: NAME: NOVOFINE 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 21E04Y. THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION.

    Description of Event or Problem · 0

    [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). LOCAL REDNESS (SERIOUS INJURY) [INJECTION SITE ERYTHEMA]. LOCAL SWELLING (SERIOUS INJURY) [INJECTION SITE SWELLING]. THE NEEDLE TIP WAS BLOCKED [DEVICE OCCLUSION]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE RECEIVED VIA REGULATORY AUTHORITY FROM CHINA WAS REPORTED BY A HEALTH CARE PROFESSIONAL NOS AS "LOCAL REDNESS (SERIOUS INJURY) (INJECTION SITE REDNESS)" BEGINNING ON (B)(6) 2023, "LOCAL SWELLING (SERIOUS INJURY) (INJECTION SITE SWELLING)" BEGINNING ON (B)(6) 2023, "THE NEEDLE TIP WAS BLOCKED (DEVICE BLOCKAGE)" BEGINNING ON (B)(6) 2023, AND CONCERNED A 80 YEARS OLD PATIENT WHO WAS TREATED WITH NOVOFINE 32G 6 MM (NEEDLE) FROM ON (B)(6) 2023 FOR "DEVICE THERAPY". THE PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX (BMI) WERE NOT REPORTED. DOSAGE REGIMENS: NOVOFINE 32G 6 MM: ON (B)(6) 2023 TO NOT REPORTED. MEDICAL HISTORY WAS NOT PROVIDED. PATIENT WAS USING NOVOFINE 32G 6 MM (NEEDLE) IN CONJUNCTION WITH NOVO NORDISK ADMINISTRATION DEVICES FOR SUBCUTANEOUS INJECTION OF MEDICATION. ON (B)(6) 2023 , AT 7:30 AM WHEN THE PATIENT INJECTED INSULIN (NON SPECIFIED), THE NEEDLE TIP WAS BLOCKED. PATIENT EXPERIENCED LOCAL REDNESS AND SWELLING (WITH A SEVERITY OF SERIOUS INJURY) THE NEEDLE WAS REPLACED WITH A NEW ONE, AND THE NEW NEEDLE WAS USED WITH NOVOPEN FOR SUBCUTANEOUS INJECTION AND COULD BE USED NORMALLY. IT WAS REPORTED THAT THE EVENT COULD PERHAPS HAPPENED DUE TO IMPROPER USE BY THE PATIENT. BATCH NUMBERS: NOVOFINE 32G 6 MM: 21E04Y. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "LOCAL REDNESS (SERIOUS INJURY) (INJECTION SITE REDNESS)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "LOCAL SWELLING (SERIOUS INJURY) (INJECTION SITE SWELLING)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE NEEDLE TIP WAS BLOCKED (DEVICE BLOCKAGE)" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE. IN ORDER TO PROTECT THE SAFETY OF PATIENT IT WILL, IN RARE CASES, BE REQUIRED TO DISASSEMBLE THE MEDICAL DEVICE IMMEDIATELY IN A WAY WHERE IT IS NOT SUBSEQUENTLY POSSIBLE TO REASSEMBLE IT (E.G. DESTRUCTIVE TESTING OR ALTERING OF THE MEDICAL DEVICE). THE DISASSEMBLED MEDICAL DEVICE WILL BE STORED WITH THE SAME RETENTION PERIOD AS OTHER COMPLAINT SAMPLES. PRELIMINARY MANUFACTURER'S COMMENT: 30-NOV-2023: THE SUSPECTED DEVICE NOVOFINE NEEDLE HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. BATCH TREND ANALYSIS OR REFERENCE DEVICE ANALYSIS WILL BE PERFORMED. WITH VERY LIMITED INFORMATION REGARDING HANDLING OF THE SUSPECTED DEVICE REPORTED IN THE CASE INCLUDING REUSE OF NEEDLE, IT IS NOT POSSIBLE TO ELUCIDATE A CLEAR ROOT CAUSE FOR THE EXPERIENCED ADVERSE EVENTS. REPORTER COMMENT: INSULIN (NON SPECIFIED) HENCE NOT CODED WITH A VALID PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169711 NOVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S N/A 21E04Y

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Other