[901026]
Arm hurting, needle had broken off and was still in child's arm [device failure]. Case description: 15-day alert. This case, (b) (4), is a solicited report from united states referring to a female pt (age not reported). A physician (also the pt's mother) reported the event from a genentech sponsored pt support program for nutropin aq. Past medical history included asthma. No concurrent conditions or allergies were reported. Concomitant medications included fluticasone propionate. In (b) (6) 2008, the pt received somatropin (0. 9 mg, qd, subcutaneous, lot number not reported) with nutropin aq pen for treatment of short stature/growth failure. Prior to the event, somatropin with nutropin aq pen was most recently received on (b) (6) 2008. The first puncture date of product container in question was not reported. The pt's prior history of exposure to product lot number in question was not reported. On (b) (6) 2008, the reporter was having a hard time getting the dose knob to lock into place. The reporter pressed the nutropin aq pen device hard while trying to get the dose knob to click into place. After giving the injection, the reporter noted the needle was no longer in the nutropin aq pen device. On the morning of (b) (6) 2008, the pt complained that her arm was hurting. The pt was taken to urgent treatment center for an x-ray of the left arm. The needle, which had broken off, was still in the child's arm (device failure). The child was put under anesthesia, and the needle was removed surgically. The pt was released from the hospital later the same day. The physician had been using the passive shield guard. The active shield guard was sent to the physician. Using 29 gauge 1/2-inch needles, the physician reported she had since given two injections with no problems. On (b) (6) 2008, the physician had a problem with the dose knob not clicking. She reported that she may have had her thumb on the white reset button, and noted that she did not know this could prevent the dose knob from locking in place. The pt's continued/or discontinued use of product lot number in question was not reported. Whether the pt switched to another lot number of the product, and if so, what was the pt's response was not reported. Treatment with somatropin was reported as ongoing. The action taken with the nutropin aq pen was not reported. The event outcome was not reported. Reports from pt support programs are regarded as solicited in nature and an implied causality cannot be inferred. No other etiologic info was reported. Additional info will be requested. If received, the case will be updated accordingly. This report was forwarded to genentech product quality (b) (4).
Patient Sequence No: 1, Text Type: D, B5