SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT, CORRUGATED; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C37101306J |
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 10/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that during pre-testing an air leak was detected.No adverse effects reported.
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Manufacturer Narrative
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Other text: d4: udi section 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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Manufacturer Narrative
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Email is: (b)(6).One device sample was received without its original packaging.Three photos were included for evaluation; photos showed perforated tube in the complaint sample.Per visual inspection, it was not possible to detect any damage or perforation in the breathing circuit assembly.A leak test was performed, and a leak was detected during the test; the complaint was confirmed.Based on the analysis conducted in the sample provided, the potential root cause of this issue is associated with the manufacturing process, this is because the forming blocks have some damage inside, causing this type of problems in the extruded product.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The complaint fault has been escalated to address a full root cause investigation and is currently in the investigation phase.
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Search Alerts/Recalls
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