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Model Number 158101310190 |
Device Problem
Restricted Flow rate (1248)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Exp date: (b)(6) 2020.Manuf.Date: (b)(6) 2015 based on the available information, this event is deemed a reportable malfunction.Additional patient/event information was requested but was not received, should additional information become available, a follow-up report will be submitted.There is one (1) other device associated with this product complaint.A separate fda form 3500a has been generated to address each device.Reported to the fda on: (b)(6) 2016.(b)(4).
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Event Description
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A nurse reported that "the urine does not flow into the bag.Probably the problem is settled in a non-return valve in a bag." there was no patient harm reported as a result of the device malfunction.
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Manufacturer Narrative
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This supplemental report is being submitted after a detailed batch review was performed.There were no discrepancies related to complaint issue found.Additionally after reviewing a photo received, it was noted that the picture showed the stop flow during closed position of open/close tap.In the closed position, urine does not flow to the bag.When open/close tap is in opened position, urine should flow to the bag.A previous investigation is applicable to this complaint and the investigation has been closed.Therefore, this complaint will be closed without further action.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).
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Search Alerts/Recalls
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