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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Manufacturer Narrative
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Other text: b3: month and year of event have been provided, day is unknown.D4: udi section is unavailable.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 pre-testing, there was a leak.No adverse effects or injury reported.
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Manufacturer Narrative
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Device evaluated by manufacturer and h6.Evaluation codes: updated.Email is: (b)(6).Four photos and one device sample were received without the original package.Per visual inspection, embedded resin was found on the corrugated tube.The complaint was confirmed, the breathing circuit leaked.The root cause was due to manufacturing caused by the embedded resin during the extrusion process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The manufacturer will continue monitoring this failure condition in this product for threshold or escalation.
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Search Alerts/Recalls
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