BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOTWIST 8 MM (30G)

    MDR report key: 5868150 · Received August 11, 2016

    Report

    Report Number
    9681822-2016-00002
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 22, 2016
    Manufacturer
    NOVO NORDISK A/S, MS HJOERRING
    Product Code
    FMI
    PMA / PMN Number
    K093109
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CASE DESCRIPTION: MEDICAL HISTORY INCLUDED NOONAN SYNDROME, AND NEEDLES HAVE BROKEN OFF IN THE PATIENT'S LEG ON TWO PREVIOUS UNSPECIFIED OCCASIONS WITHIN THE LAST MONTH BUT WAS STILL ON THE SURFACE (A TINY BIT) AND COULD BE PULLED OUT (LOT NO. FOR THESE NEEDLES WAS UNKNOWN). CONCOMITANT PRODUCTS INCLUDED - NORDITROPIN (SOMATROPIN) POWER AND SOLVENT FOR SOLUTION FOR INJECTION, MULTIVITAMIN (ASCORBIC ACID, CALCIUM PANTOTHENATE, ERGOCALCIFEROL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE), LEVOTHYROXINE (LEVOTHYROXINE), AND MIRALAX (MACROGOL 3350). TREATMENT INCLUDED - ADVIL (MEFENAMIC ACID). THE PATIENT WAS INJECTING HER MEDICINE IN HER THIGH AS SHE HAD FOR THE LAST APPROXIMATELY TWO YEARS PRIOR. THE NEEDLE COULDN'T BE RETRIEVED BY PARENTS. THE NEEDLE REMAINED UNDER THE SKIN AND CAUSED PAIN IN HER LEG. THE MOTHER REPORTED THAT SHE TOOK HER DAUGHTER TO THE EMERGENCY ROOM, WHERE SHE WAS EXAMINED AND THEY COULDN'T SEE THE NEEDLE. MULTIPLE X-RAYS SHOWED BOTH ON (B)(6) 2016 AND ON AN UNKNOWN DATE THAT THE NEEDLE WAS TOO DEEP TO RETRIEVE. THE DOCTOR IN THE EMERGENCY ROOM (ER) STATED HE DID NOT THINK IT WAS WISE TO REMOVE THE NEEDLE BECAUSE WAS TOO DEEP AND IT WAS DETERMINED IT SHOULD BE LEFT UN-EXTRACTED FROM THE PATIENT'S THIGH. THE PATIENT WAS IN PAIN AND THEY LEFT HER WITH CRUTCHES. SHE CONTINUED TO BE IN PAIN WHEN SHE WALKED OR MOVED HER LEG. THE PATIENT HAD ADVIL FOR HER PAIN OF THIS INJURY. ACTION TAKEN TO NOVOTWIST 8 MM (30G) WAS NOT REPORTED. HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS SUPPOSED TO GET A NEW TYPE OF NEEDLE OVERNIGHT BUT IT WASN'T PROPERLY FOLLOWED THROUGH. ON 17-AUG-2016 A CORRECTION WAS PERFORMED: PMA/510(K) NUMBER HAS BEEN UPDATED TO 'K093109'.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). NEEDLE BREAKAGE IN THIGH AND THE NEEDLE REMAINS UNDER THE SKIN [NEEDLE ISSUE]. LEG PAIN [PAIN IN EXTREMITY]. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "NEEDLE BREAKAGE IN THIGH AND THE NEEDLE REMAINS UNDER THE SKIN" BEGINNING ON (B)(6) 2016, AND "LEG PAIN" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH NOVOTWIST 8 MM (30G) (NOVOTWIST) FROM UNKNOWN START DATE AND ONGOING DUE TO "NOONAN SYNDROME". MEDICAL HISTORY INCLUDED NOONAN SYNDROME, AND NEEDLES HAVE BROKEN OFF IN HER DAUGHTER'S LEG ON TWO PREVIOUS UNSPECIFIED OCCASIONS. PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WERE NOT REPORTED. CONCOMITANT PRODUCTS INCLUDED - NORDITROPIN (SOMATROPIN) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION A MOTHER REPORTED THAT HER DAUGHTER, WHO WAS RECEIVING TREATMENT WITH NOVOTWIST NEEDLES FOR NORDITROPIN, HAD THE NEEDLE BREAK OFF INTO HER THIGH, WHEN SHE WAS INJECTING HERSELF AT 7:30 PM ON (B)(6) 2016. THE NEEDLE REMAINED UNDER THE SKIN AND CAUSED PAIN IN HER LEG. THE MOTHER REPORTED THAT SHE TOOK HER DAUGHTER TO THE EMERGENCY ROOM WHERE THEY DID X-RAYS, CONFIRMING THE NEEDLE WAS UNDER THE SKIN. THE DOCTOR IN THE EMERGENCY ROOM (ER) STATED HE DID NOT THINK IT WAS WISE TO REMOVE THE NEEDLE BECAUSE WAS TOO DEEP. THE PATIENT DID NOT RECEIVE ANY TREATMENT OTHER THAN CRUTCHES. IN ADDITION, THE MOTHER REPORTED THAT THE NEEDLES HAD BROKEN OFF IN HER DAUGHTER'S LEG ON TWO PREVIOUS UNSPECIFIED OCCASIONS. ON BOTH OCCASIONS HER DAUGHTER WAS ABLE TO PULL THE NEEDLE OUT OF HER LEG HERSELF. ACTION TAKEN TO NOVOTWIST 8 MM (30G) WAS REPORTED AS NO CHANGE. THE OUTCOME FOR THE EVENT "NEEDLE BREAKAGE IN THIGH AND THE NEEDLE REMAINS UNDER THE SKIN" WAS NOT RECOVERED. THE OUTCOME FOR THE EVENT "LEG PAIN" WAS NOT RECOVERED.

    Description of Event or Problem · 1

    THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITIES CASE FROM THE UNITED STATES WAS INITIALLY REPORTED BY A CONSUMER AS "NEEDLE BREAKAGE IN THIGH AND THE NEEDLE REMAINS UNDER THE SKIN" BEGINNING ON (B)(6) 2016, AND "LEG PAIN" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A (B)(6) YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOTWIST 8 MM (30G) (NOVOTWIST) FROM UNKNOWN START DATE AND ONGOING DUE TO "NOONAN SYNDROME". INVESTIGATIONAL RESULTS: NAME: NOVOTWIST 30G (B)(4) NEEDLES, BATCH NUMBER: 15A15N. 1ST INVESTIGATIONAL RESULT: A BATCH TREND REPORT WAS CREATED. NOTHING ABNORMAL WAS FOUND. 2ND INVESTIGATIONAL RESULT: MICROSCOPIC EXAMINATION PERFORMED. NEEDLES TESTED FOR RESISTANCE TO BREAKAGE. AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. DURING INVESTIGATION IT WAS NOT POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE SAMPLE OF THE BATCH IN QUESTION. THE BATCH DOCUMENTATION WAS REVIEWED. NOTHING ABNORMAL WAS FOUND. A BATCH TREND REPORT WAS CREATED. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE COMPLAINT WAS REGISTERED IN THE NOVO NORDISK COMPLAINT HANDLING SYSTEM. SINCE LAST SUBMISSION OF THE CASE, THE FOLLOWING WAS UPDATED: INVESTIGATIONAL RESULT. SUSPECT DEVICE NOVOTWIST 8MM EXPIRATION DATE UPDATED. AGE AT TIME OF EVENT UPDATED. INITIAL REPORTER ALSO SENT REPORT TO FDA UPDATE. FINAL MANUFACTURER'S COMMENT (B)(6) 2016 AS THE NEEDLE OR PART OF IT 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 (B)(4). EVALUATION SUMMARY: INVESTIGATION RESULTS (B)(4). A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. (B)(4). MICROSCOPIC EXAMINATION PERFORMED. NEEDLES TESTED FOR RESISTANCE TO BREAKAGE. AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. DURING INVESTIGATION IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE SAMPLE OF THE BATCH IN QUESTION. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND. (B)(4). A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT(S) FOR FURTHER INVESTIGATIONS. THE COMPLAINT HAS BEEN REGISTERED IN THE NOVO NORDISK COMPLAINT HANDLING SYSTEM. INVESTIGATION RESULTS LOOKUP, RESULT CODES: GENERAL : NO SAMPLE AVAILABLE - DEVICE. GENERAL : BATCH TREND. GENERAL : REFERENCE SAMPLE NORMAL. GENERAL : BATCH RECORD NORMAL. REMARKS FOR RESULT CODES: CONCLUSION CODE: NO SAMPLE- ROOT CAUSE DESCRIPTION: CORRECTIVE ACTION DESCRIPTION (B)(4). NO CORRECTIVE OR PREVENTIVE ACTIONS REQUIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522971 NOVOTWIST 8 MM (30G) NEEDLE FMI NOVO NORDISK A/S, MS HJOERRING N/A 15A15N

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R| S