SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Model Number C37101307 |
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 06/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: b3: month and year are known, date is unknown.D4: udi number, 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 the device leaks.No patient involvement.
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Manufacturer Narrative
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Other text: h3 and h6 evaluation codes updated.Device evaluation: one device and four (4) photos were returned for investigation.The photos showed a damaged tube which was confirmed by visual inspection.A leak test was then done where an air leak was confirmed.The root cause of this issue was found to be due to manufacturing.More specifically damage or wear and tear to the corrugation forming block.The worn block(s) were identified and replaced.Review of the device history record showed no non-conformities of the reported lot number.
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Search Alerts/Recalls
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