Model Number UNKNOWN |
Device Problems
Bent (1059); Break (1069); Fracture (1260); Human Factors Issue (2948); Device Handling Problem (3265)
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Patient Problems
Awareness during Anaesthesia (1707); Device Embedded In Tissue or Plaque (3165); No Information (3190)
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Event Date 06/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4).Currently the device related data (item number, lot) 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).Tentative summarizing translation from initial reporter's narrative: female patient ((b)(6)) sectio, needle broke during difficult puncture (first puncture not successful and needle broke, second puncture for spinal anaesthesia successful), fragment of first needle retrieved during surgical intervention 2 days later.Packaging of needle has been disposed.
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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).Detailed device related data (item number, lot) is unavailable.Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Tentative summarizing translation from initial reporter's narrative: female patient ((b)(6)) sectio, needle broke during difficult puncture (first puncture not successful and needle broke, second puncture for spinal anaesthesia successful), fragment of first needle retrieved during surgical intervention 2 days later.Packaging of needle has been disposed.
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Search Alerts/Recalls
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