Model Number 121163-30A |
Device Problem
Crack (1135)
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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 08/13/2019 |
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)(4) 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: leakage at the hub needle connection upon priming of needle.All outstanding needles of affected lot number have been collected from all clinical areas and stores.
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Manufacturer Narrative
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Event took place in the uk and has been reported through british distribution subsidiary pajunk medical ltd.Based on risk assessment and clinical report this file is considered as closed.
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Event Description
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Irn# (b)(4).Initial reporter´s narrative: leakage at the hub needle connection upon priming of needle.All outstanding needles of affected lot number have been collected from all clinical areas and stores.
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Search Alerts/Recalls
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