Model Number 321151-31A |
Device Problems
Fitting Problem (2183); Device Issue (2379); Device Misassembled During Manufacturing /Shipping (2912); Incorrect Device Or Component Shipped (2962); Mechanical Jam (2983)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 06/21/2016 |
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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Internal report-number: (b)(4).Tentative summarizing translation of initial reporter's narrative: spinal needle does not fit with introducer.
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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: spinal needle does not fit with introducer.
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Search Alerts/Recalls
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