Description of Event or Problem · 1
ANOTHER "NEEDLE BROKEN" 10 DAYS AGO, ON HIS THIGH (NEEDLE ISSUE) NEEDLE WAS BROKEN WHEN HE PERFORMED INJECTION AT ABDOMEN (NEEDLE ISSUE). CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT: NO. THIS SPONTANEOUS REPORT RECEIVED FROM (B)(6), REPORTED BY A CONSUMER AS "NEEDLE WAS BROKEN WHEN HE PERFORMED INJECTION AT ABDOMEN" AND "ANOTHER NEEDLE BROKEN 10 DAYS AGO, ON HIS THIGH" CONCERNS A MALE PATIENT (AGE: UNKNOWN) TREATED WITH NOVOFINE 8 MM (30 G) (NEEDLE) (DRUG START DATE UNKNOWN, DRUG STOP DATE UNKNOWN) FOR DEVICE THERAPY. PATIENT'S HEIGHT: NOT REPORTED. MEDICAL HISTORY: NOT REPORTED. THE PATIENT BOUGHT NOVOFINE 30 G (BATCH NUMBER 11M12Y, LENGTH 8 MM) FROM A LOCAL PHARMACY. IN THE EVENING OF (B)(6) 2013, THE PATIENT FOUND THE NEEDLE WAS BROKEN WHEN HE PERFORMED INJECTION AT ABDOMEN. SINCE THE PATIENT HAD NO ABNORMAL FEELING, HE DID NOT GO TO SEE THE PHYSICIAN. THE PATIENT STATED THAT THE NEEDLE HAD BEEN USED FOR A WEEK WHEN THE EVENT HAPPENED. THE PATIENT ALSO REPORTED THAT HE EXPERIENCED ANOTHER "NEEDLE BROKEN" 10 DAYS AGO WHEN HE USED ANOTHER NOVOFINE 30 G, 8 MM (BATCH NUMBER WAS NOT REPORTED) TO PERFORM INJECTION ON HIS THIGH. THE PATIENT EXPERIENCED "BROKEN NEEDLE" TWICE WITHIN 60 DAYS. THE PATIENT COMPLAINED THAT THE NEEDLE BROKEN IN HIS THIGH CAUSED UNCOMFORTABLE FEELING WHILE WALKING, HOWEVER HE DID NOT VISIT PHYSICIAN. SO FAR NO ACTION HAS BEEN TAKEN FOR THE REPORTED EVENTS. THE PATIENT ADMITTED THE NEEDLE WAS MULTI-USED AND HE ALWAYS USED ONE NEEDLE FOR ONE PENFILL. THE PATIENT REPORTED THAT THE FIRST NEEDLE WAS BROKEN IN LEFT LOWER QUADRANT OF HIS ABDOMEN; THE SECOND NEEDLE WAS BROKEN ON HIS LATERAL THIGH. BOTH NEEDLES WERE BROKEN FROM ROOT PART. THE NEEDLE HAS NOT YET BEEN REMOVED AT THE TIME OF REPORTING. NO X-RAY EXAMINATION WAS PERFORMED. THE PHYSICIAN CONSIDERED THE EVENTS WOULD NOT INTERFERE THE PATIENT'S DAILY LIFE AND IT WAS NOT NECESSARY TO REMOVE THE NEEDLE. THE PHYSICIAN ALSO STATED THAT IT COULD BE DIFFICULT TO REMOVE THE NEEDLE SURGICALLY. ACTION TAKEN TO NOVOFINE WAS NOT REPORTED. THE OVERALL OUTCOME OF THE EVENTS WAS REPORTED AS NOT YET RECOVERED. REPORTER COMMENT: THE COMPLAINED NEEDLES WERE DISCARDED, THEREFORE NO SAMPLES AVAILABLE FOR INVESTIGATION.