Model Number 531185-31A |
Device Problems
Partial Blockage (1065); Complete Blockage (1094); Kinked (1339); Obstruction of Flow (2423)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 01/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6).At this time, information on the device and the incident is poor.No information about the device's whereabouts.Follow up will be sent as soon as more information becomes available.Device not returned.
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Event Description
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(b)(4).Users narrative tentative translation: catheter does not go smoothly through needle, kinks.
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Manufacturer Narrative
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Event took place in (b)(6).Isolated event.Human error in manufacturing.File is considered as closed.
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Event Description
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(b)(4).Users narrative tentative translation: catheter does not go smoothly through needle, kinks.Needle is blocked.
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Search Alerts/Recalls
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