Model Number CB002 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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4581-appropriate clinical signs, symptoms, conditions term/code not available: unspecified motor skills issue.The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 21 mar 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Event Description
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Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: (b)(6) 2023.Fda medwatch / fda user facility report mw report (b)(4) reported, the onq pump infusion completed about 24 hours earlier than expected.The patient noted the pump [was] complete at 1900; the pump should have finished at 2200 the next day.The patient reported a return of motor and sensation after the infusion was noted to be complete; there were no reported signs of local anesthetic systemic toxicity (last).
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Manufacturer Narrative
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The device history record for lot 30212652 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 may 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Search Alerts/Recalls
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