SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number CA1300/400/004JP |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that after opening and during pre-testing, the customer checked the gas sampling line for clogging.They stopped using it.No adverse effects have been reported.
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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: expiration date and h4: manufacture date are unknown, no information is available based on the reported lot number.G5: 510k is blank, device is exempt.Device evaluation: one device was returned for investigation.Visual inspection of the returned components revealed a tear in the breathing circuit.During functional testing, an occlusion was confirmed.No other anomaly was observed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.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.
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Manufacturer Narrative
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Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.One device sample was received without its original package.Four photos were included for evaluation; photos showed the complaint sample.The complaint was confirmed by visual inspection, occlusion tube was found.The root cause was manufacturing during the bond luers operation.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.All mitigations in place were verified and it was confirmed has been executed according, the manufacturer will monitor this failure condition in this product for threshold or escalation.
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Search Alerts/Recalls
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