SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C37101307J |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Day of event is unknown, lot number, expiration date and udi information unknown, 510k unknown, device manufacture date unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that during the pre-use check, leakage of air from the product was observed.After it was changed to another new one, the event was settled.No adverse patient effects were reported by the customer.
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Manufacturer Narrative
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Device evaluation: one device was returned for investigation.Visual inspection confirmed there was an embedded resin defect.The complaint was confirmed.Root cause of the leaking was due to embedded resin being found on the corrugated tube.No lot number was provided, therefor no device history performance report (dhr) review could be completed.This issue will continue to be monitored and further actions taken accordingly.
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Search Alerts/Recalls
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