It was reported that the bd intima-ii¿ closed iv catheter system's indwelling needle tube ruptured during the ct scan, causing blood leakage.The following information was provided by the initial reporter, translated from (b)(6): "on (b)(6) 2021 at 15:41, due to the infusion of iodophoresis for ct-enhanced scanning, an indwelling needle was used, resulting in a rupture of the indwelling needle tube (about 0.5 cm from the connection port) on the same day, which affected the victim: blood leakage from the needle tube, local pain, affecting the imaging results, potential contrast agent leakage and local necrosis, on (b)(6) at 10:30, the needle was immediately withdrawn to stop the bleeding by compression, comforting the patient and family members at 10:30 on (b)(6), he immediately removed the needle to stop the bleeding, reassured the patient and family, re-punctured the tube for imaging, observed the local condition of the puncture, and applied wet compresses.The situation improved the next day.No device combination.".
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Investigation summary: in response to the event reported, a device history review was conducted for lot number 1203147.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Based on the description of the event, our engineers were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection.The bd intima-ii is an infusion only device and is not rated for high pressure injections.Bd will continue to track and trend for this issue.
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