Model Number 405672 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 08/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that 2 tray spn whit 25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -treatment failed to work during use.The following information was provided by the initial reporter: material no.405672 batch no.0001283016.Two patients on (b)(6) 2020, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.Sequestered tray and spinal medication is in the managers office awaiting pick 11p from supply chain.
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Manufacturer Narrative
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The following information has been corrected: b.1.Adverse type: reported issue is both an adverse event and product problem.B.2.Event attributed to: required intervention.B.5.Describe event or problem: it was reported that 2 tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -treatment failed to work during use.Product defect resulted in medical intervention with a change in treatment, (general anesthesia).The following information was provided by the initial reporter: material no.405672 batch no.0001283016 two patients on 8/11/20, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.Sequestered tray and spinal medication is in the managers office awaiting pick 11p from s11ppply chain.B.6.Relevant tests/laboratory data: one patient had to have general anesthesia since the spinal did not work.H.1.Type of reportable event: serious injury.
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Event Description
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It was reported that 2 tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -treatment failed to work during use.Product defect resulted in medical intervention with a change in treatment, (general anesthesia).The following information was provided by the initial reporter: material no.405672 batch no.0001283016 two patients on 8/11/20, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.Sequestered tray and spinal medication is in the managers office awaiting pick 11p from s11ppply chain.
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Search Alerts/Recalls
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