SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT, EXPANDABLE; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number CA1300/4K2/000JP |
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 09/01/2023 |
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 section, expiration date and h4: manufacture date are unavailable based on the reported lot number.G5: 510k is blank, device is exempt.Device evaluation: one device was received with all of it's kit components.The complaint was confirmed during functional testing.No other anomaly was observed.It was considered that the leakage occurred before being supplied to the investigating site.To further investigate the cause of the observed condition, the device was forwarded to another investigation site for additional analysis.A supplemental report will be provided when further information becomes available.A review of the device history record (dhr) shows there were no observations or nonconformities 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 during pre-testing, there was a leak.Discontinued use of that device due to the leak.No report of adverse effects.
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Manufacturer Narrative
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D3, g1,2 email is: regulatory.Responses@icumed.Com.Secondary investigation/device analysis: per visual inspection, it was not possible to detect damage in the ?wye? connector assembly.Per functional testing, the result of the circuit tube test was rejected because there was an air leak.The complaint was confirmed.A root cause could not be associated with 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.While a root cause was unable to be determined, the reported issue has been escalated and is currently being reviewed.
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