Model Number 001156-81 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Fracture (1260); Leak/Splash (1354); Device Handling Problem (3265)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/25/2016 |
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) distributor (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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(b)(4).Summarizing tentative translation from initial reporter: leakage at needle hub.
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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).Summarizing tentative translation from initial reporter: leakage at needle hub.
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Search Alerts/Recalls
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