Model Number 041151-30A |
Device Problems
Failure To Adhere Or Bond (1031); Break (1069); Nonstandard Device (1420); Product Quality Problem (1506); Device Handling Problem (3265)
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Patient Problems
Inadequate Pain Relief (2388); No Information (3190)
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Event Date 05/17/2016 |
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).Summarising translation from user's narrative: during puncture, the spinal needle broke apart at the base.
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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).Summarising translation from user's narrative: during puncture the spinal needle broke apart at the base.
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Search Alerts/Recalls
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