Model Number 501151-29AB |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problems
No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
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Event Date 02/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Vent took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (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.
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Event Description
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(b)(4).Summarizing tentative translation of initial reporter´s narrative: upon removal of the spinal needle the hub came off the needle.
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Event Description
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Irn# (b)(4).Summarizing tentative translation of initial reporter´s narrative: upon removal of the spinal needle the hub came off the needle.
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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).Based on risk management and clinical assessment this file is considered as closed.
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Search Alerts/Recalls
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