Investigation summary: a device history review was conducted for lot number: 2011060.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.
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It was reported that the bd intima-ii¿ closed iv catheter system experienced the needle completely came out of skin.The following information was provided by the initial reporter: on (b)(6) 2022, when the family of the child was at home, they found that the child's indwelling needle had completely come out of the skin.They cut off the fixed tape with scissors and found that the indwelling needle had no needle tip.
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