Model Number 1185-3E080 |
Device Problems
Partial Blockage (1065); Product Quality Problem (1506)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 11/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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: needle is blocked.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.Device not returned.
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Event Description
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(b)(4).Summarizing tentative translation from initial reporter´s narrative: needle is blocked.
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Search Alerts/Recalls
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