It was reported that the bd intima-ii¿ closed iv catheter system end cap was loose.The following information was provided by the initial reporter, translated from chinese: "9:16, before the nurse prepared the infusion for the patient, it was found that the white interface of the indwelling needle was loose.No adverse consequences were caused.".
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Investigation summary: a device history review was conducted for lot number: 1350195.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.
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