Model Number 001157-00Z |
Device Problems
Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371); 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 05/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
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Event Description
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(b)(4).Tentative summarizing translation of initial reporter's narrative: catheter got loosened from hub; happened 3 times.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Tentative summarizing translation of initial reporter's narrative: catheter got loosened from hub; happened 3 times.Amendment: lot affected is unknown, packaging/ labeling has been disposed by user.
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Search Alerts/Recalls
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