Model Number 321151-31A |
Device Problem
Fracture (1260)
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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 10/02/2018 |
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) distribution subsidiary (b)(6).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.This case is reported late because details (device, event) became available 2018-11-01.
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Event Description
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Irn# (b)(4).Summarizing translation of initial reporter´s narrative: cannula got loosened from hub.
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (b)(4).Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.This case is reported late because details (device, event) became available 2018-11-01.
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Event Description
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Irn# (b)(4).Summarizing translation of initial reporter´s narrative: cannula got loosened from hub.
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Search Alerts/Recalls
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