Model Number 041151-29A |
Device Problems
Partial Blockage (1065); No Flow (2991)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/01/2016 |
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).Summarizing tentative translation from initial reporter's narrative: needles are blocked.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.Not returned.
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Event Description
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(b)(4).The device identifier (item number and batch) have been anticipated based on supplier history file and delivery notes.Details have not been provided by the customer.Summarizing tentative translation from initial reporter´s narrative: needles are blocked.
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Search Alerts/Recalls
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