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
malfunction
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Manufacturer Narrative
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Oem manufacture: (b)(4).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 the tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia, failing 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.
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Event Description
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It was reported that the tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia, failing 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.
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Manufacturer Narrative
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H6: investigation summary: a review of the device history record noted no issues relating to the reported failure mode for 405672, lot # 0001283016.No complaint sample or photo was provided for evaluation.Although a sample was not provided for evaluation, the plant stability program runs a single lot each year to ensure their processes does not affect the drug potency.The stability program returned acceptable results.Consequently, the investigation was not able to confirm the reported failure mode.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.All indicators suggest product 405672, lot # 0001283016, contained a drug with acceptable potency.In addition, the stability program tests one sample of bupivacaine on a yearly basis.The bupivacaine potency result met acceptance criteria and the assay results were all within the specification range of 6.98-8.03 mg/ml.Based on the complaint investigation, the failure mode could not be confirmed and as a result a probable root cause could not be identified.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any corrective actions for this complaint.H3 other text : see h10.
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Search Alerts/Recalls
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