Model Number 001185-71 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Occlusion Within Device (1423)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/18/2016 |
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)(6) distributor.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.Not yet returned, possibly unavailable.
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Event Description
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(b)(4).Tentative summarizing translation of initial reporter's narrative: suspected occlusion in the cannula's tubing.
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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: suspected occlusion in the cannula's tubing.
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Search Alerts/Recalls
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