Model Number 201185-40E |
Device Problems
Fluid/Blood Leak (1250); Nonstandard Device (1420); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); No Flow (2991)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in the netherlands and has been reported through (b)(4) distribution subsidiary (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).Summarizing translation from initial reporters narrative: fluid leakage at the tube-to-catheter-connection.
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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).Summarizing translation from initial reporter's narrative: fluid leakage at the tube-to-catheter-connection.
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Search Alerts/Recalls
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