Model Number 321151-30C |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problems
Awareness during Anaesthesia (1707); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6).Device has not yet been sent back for evaluation.Information is poor.Follow up report will be sent as soon as further information / device evaluation is available.Device not sent back for evaluation.
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Event Description
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(b)(4).Summarizing translation from initial reporter's narrative: upon lumbar puncture, the needle had to be adjusted 2 times due to bone contact.Upon removal for reinsertion, the needle broke apart.Fragment had to be retrieved with tweezers.Lp has been conducted afterwards using another needle.
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Manufacturer Narrative
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We consider this file as closed.
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Event Description
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Internal report number: (b)(4).Summarizing translation from initial reporter's narrative: upon lumbar puncture the needle had to be adjusted 2 times due to bone contact.Upon removal for reinsertion the needle broke apart.Fragment had to be retrieved with tweezers.Lp has been constructed afterwards using another needle.
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Search Alerts/Recalls
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