It was reported that the unit packaging of the bd intima-ii¿ closed iv catheter system was found damaged.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted to hospital due to lumbar spinal stenosis, preoperative anti-inflammatory, fluid infusion.On (b)(6) 2022, the indwelling needle was replaced, and the package of the closed intravenous indwelling needle was found to be damaged, and it was replaced immediately.".
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Initial reporter e-mail: unknown.Investigation summary: a sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.A device history review was conducted for lot number 2110919.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.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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