SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EXPANDABLE BREATHING CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C45101344-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 10/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: b3: month and year of event have been provided, day is unknown.D4: udi number is unknown; no information has been provided to date.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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Event Description
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It was reported that during a pre-use check, a leak in the anesthesia bag was suspected.
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Manufacturer Narrative
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Email is: (b)(6).One device sample was received without the original packaging.Five (5) photos were included for evaluation; photos show a tear in the breathing bag.Per visual inspection, it was possible to detect a tear in the breathing bag.A leak test was performed, and a leak was detected during the test; the complaint was confirmed.Based on the analysis conducted a root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Notification was made to the supplier for the issue.
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Search Alerts/Recalls
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