Model Number 120066-30A |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Nonstandard Device (1420)
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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 01/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in the (b)(6) and has been reported through (b)(6) distribution subsidiary pajunk medical ltd.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).Initial reporter´s narrative: 24g x 90mm sprotte nrfit introduced to subarachnoid space, on injection immediately leaked from side of hub, tried twice with same very obvious result.Needle removed and replaced for use with successful competition.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.(b)(4).
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Event Description
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Irn# (b)(4).From initial reporter´s narrative: 24g x 90mm sprotte® nrfit introduced to subarachnoid space, on injection immediately leaked from side of hub, tried twice with same very obvious result.Needle removed and replaced for use with successful competition.
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Search Alerts/Recalls
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