Model Number 001157-01Z |
Device Problems
Break (1069); Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017); Human Factors Issue (2948); Device Handling Problem (3265)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 02/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6) and has not been reported to (b)(6) health authorities.This case in particular is considered as closed.Individual cases were reported earlier but had different root causes not affecting the patient or prior to use.Since there are additional complaints/ there is additional feedback, this has been identified to be reportable to fda.Therefore, a summarizing analysis has been conducted.The incident/ the device group is under monitoring and continuing trend analysis.Device not returned.
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Event Description
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(b)(4).User's narrative (tentative summarizing translation from (b)(6)): after joint implantation of the catheter at (b)(6) 2016, the catheter dissolved out of the bend protection after two days on station 4c.The local anesthetic flowed then some time unnoticed into the patient's bedside.The patient was not harmed.Customer: "at patient 2, the catheter leaked anesthesia and was unfortunately not to get tight.Causes insufficient anesthesia.
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Search Alerts/Recalls
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