Description of Event or Problem · 1
THE NEEDLE BROKE FROM THE ROOT PART AND PENETRATED INTO SKIN [NEEDLE ISSUE]. SOMETIMES FELT ACHE AND SHARP PAIN. [PAIN]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS IIA. THIS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER AS "THE NEEDLE BROKEN FROM THE ROOT PART" AND "SOMETIMES FELT ACHE AND SHARP PAIN", IT CONCERNS A (B)(6) MALE PT USING NOVOFINE 30G ON AN UNK DATE DUE TO TYPE 2 DIABETES MELLITUS. PT'S HEIGHT: (B)(6). MEDICAL HISTORY INCLUDES TYPE 2 DIABETES MELLITUS. THE PT HAS BEEN TREATED WITH NOVONORDISK PRODUCTS FOR ABOUT 6 YEARS. BEFORE (B)(6) 2009, THE PT WAS TREATED WITH NOVOLIN 30 R PENFILL, AND THEN HE SWITCHED TO NOVOMIX 30 PENFILL FOR UNK REASON. CURRENTLY, THE PT TAKES NOVORAPID COMBINED WITH GLARGINE FOR TREATMENT. ON (B)(6) 2010, THE PT BOUGHT A BOX OF NOVOFINE 30G FROM THE PHARMACY. ABOUT 6 PM ON (B)(6) 2010, THE PT INJECTED INSULIN ON HIS ABDOMEN WHILE SQUATTING ON THE TOILET, AND THEN FOUND THE NEEDLE OF THE SUSPECTED BATCH DISAPPEARED AFTER INJECTION AND STANDING UP (THE NEEDLE BROKEN FROM THE ROOT PART). THE PT HAS FELT ACHE AND PAIN WHEN PRESSING OR TOUCHING THE INJECTION SITE FROM TIME TO TIME FROM THE EVENT START ON (B)(6) 2010 AT ABOUT 18:00 HOURS UNTIL NOW. THE PT STATED THAT HE USED EACH NEEDLE FOR 3 TO 5 DAYS IN GENERAL, BUT THE SUSPECTED NEEDLE WAS UNUSED BEFORE THE EVENT OCCURRED. THE PT WENT TO A HOSP AND RECEIVED X-RAY EXAMINATION, WHICH REVEALED THE NEEDLE HAD PENETRATED INTO SKIN ABOUT 2 CM. THE DOCTOR MADE AN INCISION, BUT FAILED TO REMOVE THE BROKEN NEEDLE. THE DOCTOR ADVISED THAT IF THE NEEDLE COULD BE WRAPPED BY SOFT TISSUE AND NOT HARMFUL TO OTHER ORGANS, IT WAS NOT NECESSARY TO TAKE THE BROKEN NEEDLE OUT. THE PT'S WOUND WAS BANDAGED AND HE LEFT THE HOSP ON THE SAME DAY. THE PT WAS NOT HOSPITALIZED DUE TO THIS EVENT. IN (B)(6) 2010, THE PT WENT TO ANOTHER HOSP. THE DOCTOR GAVE HIM THE SAME ADVICE AS THE PREVIOUS ONE. THE PT DID NOT PAY MUCH ATTENTION TO IT, BUT SOMETIMES FELT ACHE AND SHARP PAIN. ON (B)(6) 2010, THE PT WENT TO THE FIRST HOSP AGAIN TO UNDERGO A SURGERY FOR APPENDICITIS. HE WANTED TO TAKE THIS OPPORTUNITY TO HAVE THE BROKEN NEEDLE REMOVED. THE DOCTOR DISAGREED. NOW, THE PT STILL WANTS TO HAVE THE BROKEN NEEDLE REMOVED AND THE PT AND HIS RELATIVE INSISTED ON TAKING THE BROKEN NEEDLE OUT BY SURGERY. THE PT HAS BEEN TRAINED IN THE USE OF THE SUSPECTED PRODUCT BY THE STAFF OF HOSP AND PHARMACY. THE NEEDLE WAS STORED IN A DRAWER BUT NOT IN A FRIDGE. THE REMAINING PART OF COMPLAINT SAMPLE WAS THROWN AWAY, NO SAMPLE IS AVAILABLE. A DOCTOR CONFIRMED THERE WAS A BROKEN NEEDLE IN THE PT'S BODY, BUT DID NOT DESCRIBE THE EXACT LENGTH OF THE BROKEN NEEDLE. THE DOCTOR THOUGHT SURGERY MAY NOT BE NECESSARY AND FOLLOW-UP VISIT EVERY THREE MONTHS WOULD BE FINE. IT IS REPORTED THAT NO DOCTOR THINKS THE EVENTS ARE RELATED TO THE QUALITY OF THE SUSPECTED PRODUCT. THE OUTCOME "NEEDLE BROKEN" IS REPORTED AS NOT RECOVERED. OUTCOME OF "SOMETIMES FELT ACHE AND SHARP PAIN" IS REPORTED AS NOT YET RECOVERED.