SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK SYSTEM; CATHETER, CONDUCTION, ANESTHETIC
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Catalog Number 100/391/118CZ |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3: other; device not returned to manufacturer.No device was returned for investigation.Therefore, we are unable to confirm the reported problem.If we receive the device, we will reopen the investigation for further evaluation.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
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Event Description
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It was reported that the catheter bevel was not cutting during the procedure, which occurred with two patients on the same day in different rooms.The event occurred during patient use and there was no harm, injury or adverse event.
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Search Alerts/Recalls
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