BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 32G 6 MM

    MDR report key: 17555344 · Received August 16, 2023

    Report

    Report Number
    9681821-2023-00112
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 21, 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: 21CO4Y THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NO CONCLUSION CAN BE MADE WITHOUT THE SAMPLE OR A VALID BATCH NUMBER. THE REPORTED BATCH NUMBER IS NOT VALID. 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: IMDRF CODED UPDATED INVESTIGATION RESULT UPDATED. FINAL MANUFACTURER'S COMMENT: 12-SEP-2023: THE SUSPECTED DEVICE NOVOFINE 32G 6 MM NEEDLE HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. THE REPORTED BATCH NUMBER IS NOT VALID. NO BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS PERFORMED. RELEVANT INFORMATION ON INJECTION ADMINISTRATION TRAINING AND NEEDLE RE-USAGE AND ANY DAMAGE OF NEEDLE PRIOR TO USAGE IS UNAVAILABLE FOR COMPLETE ASSESSMENT. 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 AND THE RESULTANT NEEDLE INJURY. REPORTER COMMENT: THE NOVOFINE REPORTED WAS THE FIRST TIME IT HAS BEEN USED AND HAS BEEN DISCARDED BY THE PATIENT. H3 CONTINUED: EVALUATION SUMMARY NAME: NOVOFINE® 32G ETW TIP 0.23/0.25*6MM, BATCH NUMBER: 21CO4Y THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NO CONCLUSION CAN BE MADE WITHOUT THE SAMPLE OR A VALID BATCH NUMBER. THE REPORTED BATCH NUMBER IS NOT VALID. 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

    PATIENT FELT VERY PAINFUL AT THE INJECTION SITE [INJECTION SITE PAIN]. BLEEDING OCCURRED AT THE INJECTION SITE [INJECTION SITE HAEMORRHAGE]. TISSUE DAMAGE AT THE INJECTION SITE [INJECTION SITE INJURY]. THE NEEDLE HAD A BARB [NEEDLE ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE RECEIVED VIA REGULATORY AUTHORITY NATIONAL MEDICAL PRODUCTS ADMINISTRATION(NMPA) FROM CHINA WAS REPORTED BY A HEALTH CARE PROFESSIONAL NOS AS "PATIENT FELT VERY PAINFUL AT THE INJECTION SITE(INJECTION SITE PAIN)" BEGINNING ON (B)(6) 2023, "BLEEDING OCCURRED AT THE INJECTION SITE(INJECTION SITE BLEEDING)" BEGINNING ON (B)(6) 2023, "TISSUE DAMAGE AT THE INJECTION SITE(INJECTION SITE INJURY)" BEGINNING ON (B)(6) 2023, "THE NEEDLE HAD A BARB(NEEDLE POINT BURR)" BEGINNING ON (B)(6) 2023, AND CONCERNED A 58 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOFINE 32G 6 MM (NEEDLE) FROM (B)(6) 2023 FOR "DIABETES MELLITUS", CURRENT CONDITION: DIABETES MELLITUS (TYPE AND DURATION NOT REPORTED). DOSAGE REGIMENS: NOVOFINE 32G 6 MM: (B)(6) 2023 TO NOT REPORTED; CURRENT CONDITION: DIABETES MELLITUS (TYPE AND DURATION NOT REPORTED). CONCOMITANT PRODUCTS INCLUDED - INSULIN. AT AROUND 7 A.M. ON (B)(6) 2023, THE PATIENT WAS PREPARING TO INJECT HIMSELF WITH INSULIN. THE NEEDLE WAS NEW. AFTER THE INJECTION, THE PATIENT FELT VERY PAINFUL THAT DAY, EVEN BLED AFTER REMOVING THE NEEDLE AND ALSO HAD TISSUE DAMAGE. AFTER CAREFULLY CHECKING THE NEEDLE, IT WAS FOUND THAT THE NEEDLE HAD A BARB, AND THE MANAGEMENT DOCTOR WAS IMMEDIATELY NOTIFIED. BATCH NUMBERS: NOVOFINE 32G 6 MM: 21CO4Y. THE REPORTED BATCH NUMBER OF THE NOVOFINE 32G 6 MM WAS INVALID. ACTION TAKEN TO NOVOFINE 32G 6 MM WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "PATIENT FELT VERY PAINFUL AT THE INJECTION SITE (INJECTION SITE PAIN)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "BLEEDING OCCURRED AT THE INJECTION SITE (INJECTION SITE BLEEDING)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "TISSUE DAMAGE AT THE INJECTION SITE (INJECTION SITE INJURY)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE NEEDLE HAD A BARB (NEEDLE POINT BURR)" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE. REFERENCES INCLUDED: REFERENCE TYPE: E2B AUTHORITY NUMBER, REFERENCE ID#: (B)(4), REFERENCE NOTES: NMPA (NATIONAL MEDICAL PRODUCTS ADMINISTRATION), CHN. PRELIMINARY MANUFACTURER'S COMMENT: 26-JUL-2023: THE SUSPECTED DEVICE NOVOFINE 32G 6 MM NEEDLE HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO CONCLUSION REACHED YET. REPORTER COMMENT: THE NOVOFINE REPORTED WAS THE FIRST TIME IT HAS BEEN USED AND HAS BEEN DISCARDED BY THE PATIENT. NO SAMPLES HAVE BEEN RETURNED. DUE TO THE PATIENT NOT RETURNING TO THE HOSPITAL, THE OUTCOME AND THE CAUSAL RELATIONSHIP CANNOT BE DETERMINED. OTHER INFORMATION CANNOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528630 NOVOFINE 32G 6 MM NEEDLE FMI NOVO NORDISK A/S N/A 21CO4Y

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other INSULIN (INSULIN) SOLUTION FOR INJECTION