It was reported that the bd nexiva¿ closed iv catheter system ¿ single port 20 ga 1.75 in experienced catheter splitting.The following information was provided by the initial reporter: product malfunction of ref 383518 bard nexiva closed iv catheter system 20g 1.75 in 1/1 x 45 mm.Used ultrasound to assist m placement of peripheral iv.During insertion of iv catheter, the plastic catheter split.Patient expressed feelings of pain and discomfort at that time.After withdrawing the iv from the unsuccessful iv placement attempt, this rn noted that the plastic catheter split apart from the needle during insertion.
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Device expiration date: unknown.Fda notified: the initial reporter also notified the fda via medwatch #: (b)(4).Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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