COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problem
Unraveled Material (1664)
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Patient Problems
Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)
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Event Date 05/15/2015 |
Event Type
malfunction
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Event Description
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The initial info stated that the wire unraveled.Add'l info received on (b)(6) 2015: right femoral and right internal jugular sites, at 17:15 and 18:00 delayed in medication administrations.An attempt was made to place the second line but this was unsuccessful; therefore the pt was transferred to icu.The doctor wasn't able to advance the guide wire enough to secure placement, as it would advance to a certain point and stop.During the attempt to retract the wire, it was caught on something; resulting in the wire unraveling in pt during retrieval.No pt injury occurred, and the wire and needle were retracted as one.Add'l info provided (b)(6) 2015: the delay in medication administration was due to the guide wire unraveling and the user being unable to establish central intravascular access.They did have peripheral lines, and were able to hydrate the pt and give appropriate medications, but the administration of some of these were delayed due to the staff trying to manage the central line.They have stated it is hard to say if the delayed establishment of a central line caused significant adverse events due to the pt condition and the multitude of variables.No add'l info has been provided regarding pt outcome.We will continue to monitor for similar complaints and have notified the appropriate personnel of this event.Insufficient risk due in.
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Manufacturer Narrative
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(b)(4).Event is still under investigation.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The initial information stated that the wire unraveled.Additional information received on 01jun2015: right femoral and right internal jugular sites, at 17:15 and 18:00 delayed in medication administrations.An attempt was made to place the second line but this was unsuccessful; therefore the patient was transferred to icu.The doctor wasn't able to advance the guide wire enough to secure placement, as it would advance to a certain point and stop.During the attempt to retract the wire, it was caught on something; resulting in the wire unraveling in patient during retrieval.
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