Model Number 021163-29A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/11/2019 |
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 (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).Initial reporter´s narrative: patient on elective caesarean section list.Straightforward spinal using the nr fit pajunk sprotte 25g 90mm needle via the supplied 30mm introducer needle.Injected spinal drugs uneventfully.Attempted to remove the introducer and spinal needle as a single unit whereupon the hub of the spinal needle detached from the needle leaving the needle protruding from the patient's back.The needle was subsequently removed manually and was intact.
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Event Description
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Irn# 620_109-19.Initial reporter´s narrative: patient on elective caesarean section list.Straightforward spinal using the nr fit pajunk sprotte 25g 90mm needle via the supplied 30mm introducer needle.Injected spinal drugs uneventfully.Attempted to remove the introducer and spinal needle as a single unit whereupon the hub of the spinal needle detached from the needle leaving the needle protruding from the patient's back.The needle was subsequently removed manually and was intact.
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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 evaluation this file is considered as closed.- attachment: [complaint report for 109-19.Pdf].
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Search Alerts/Recalls
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