SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C37101330-NLJ |
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 07/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the pre-testing, the device was leaking from the anesthesia bag.No adverse effects or injuries have been reported.
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Manufacturer Narrative
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Other, other text: b3: month and year of event have been provided, day is unknown.D4: udi section is unknown.G5: 510k is blank, device is exempt.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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Manufacturer Narrative
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G2 email is: (b)(4).One device sample was received without the original package.Per visual inspection, damage was detected in the breathing bag.The complaint was confirmed.It was unknown what caused the damage, and the root cause could not be traced to the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will continue to be monitored and further actions taken accordingly.
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Search Alerts/Recalls
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