Catalog Number AI-07155-IK |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, when the catheter was in use it was noted that fluid was accumulating in the sterile sheath that houses the tvp wire outside of the insertion site/hub.As a result, the staff was able to drain excess fluid from the distal end without incident.However, the staff noted slow reaccumulating of the fluid throughout the procedure, which required additional drainage.There was no report of patient complications, serious injury, or death.
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Event Description
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It was reported that, when the catheter was in use it was noted that fluid was accumulating in the sterile sheath that houses the tvp wire outside of the insertion site/hub.As a result, the staff was able to drain excess fluid from the distal end without incident.However, the staff noted slow reaccumulating of the fluid throughout the procedure, which required additional drainage.There was no report of patient complications, serious injury, or death.
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Manufacturer Narrative
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Qn#(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of "fluid accumulating in sterile sheath" is not able to be confirmed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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