Unknown manufacturer: (b)(4).Investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.
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It was reported that unspecified bd¿ optima connector leaked.The following information was provided by the initial reporter: it was reported that patient reported iv main line disconnected from picc.Fluid spill approximated at 2-3 ml on the bed. verbatim: patient reported iv main line disconnected from picc, when he got up from bed to urinate.Chemotherapy drugs infusing.Iv line has optima connector, optima injector and blue clamp.Event was caught immediately.Fluid spill approximated at 2-3 ml on the bed.
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