Catalog Number 400866 |
Device Problem
Lack of Effect (4065)
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Patient Problem
Anxiety (2328)
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Event Date 11/30/2023 |
Event Type
Injury
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Event Description
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Materials#: 400866 batch#: 0001517987.It was reported by the customer that spinal anesthesia was inadequate.Verbatim: rcc received a complaint via email.Email(s) attached.Describe event or problem: patient schedule for elective post-partum tubal ligation under spinal anesthesia.Procedure described in pse as easy spinal with easy aspiration prior to and after injection of intrathecal anesthetic (bupivacaine 0.75% with dextrose 8.25%).Despite typical dose used (12 mg), trendellenderg position, and adequate time used to set up, spinal anesthesia was inadequate.Patient became very anxious and decision to proceed to geta was made.Date of event: 30-nov-2023.
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Manufacturer Narrative
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Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Manufacturer Narrative
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Pr (b)(4) follow up mdr for device evaluation/correction: b.3 event date updated to correct date reported 30nov2023.Device evaluation : no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001517987 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Retain samples were analyzed, per the drug retain visual examination procedure, and no issues were identified.Based on the available information we are not able to identify a root cause at this time.We have notified the supplier of the reported incident.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.
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Event Description
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Materials#: 400866; batch#: 0001517987.It was reported by the customer that spinal anesthesia was inadequate.Verbatim: rcc received a complaint via email.Email(s) attached.Describe event or problem: patient schedule for elective post-partum tubal ligation under spinal anesthesia.Procedure described in pse as easy spinal with easy aspiration prior to and after injection of intrathecal anesthetic (bupivacaine 0.75% with dextrose 8.25%).Despite typical dose used (12 mg), trendelenberg position, and adequate time used to set up, spinal anesthesia was inadequate.Patient became very anxious and decision to proceed to geta was made.Date of event: 30-nov-2023.
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Search Alerts/Recalls
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