Model Number 001185-71 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Leak/Splash (1354); Nonstandard Device (1420); Product Quality Problem (1506)
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Patient Problems
Awareness during Anaesthesia (1707); Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/30/2016 |
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 from initial reporter's narrative: leakage of needle during injection.
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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 from initial reporter's narrative: leakage of needle during injection.
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Search Alerts/Recalls
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