SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C37101329-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 10/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that during pre-use checks there were leaks.No patient injury or clinical affects was 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: udi number 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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Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device sample was received without the original packaging.Three (3) photos were included for evaluation; photos show a perforation in the tube.Per visual inspection, it was not possible to detect the perforation in the corrugated tube.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 problem 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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