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 11/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a pre-use leak test, a leak was found to be present, so use was discontinued.
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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.D3, g1,2 email is: regulatory.(b)(6).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.Email is: (b)(6).One device sample was received without the original packaging.Two (2) photos were included for evaluation; photos do not show any issue in the corrugated tube and breathing bag.Per visual inspection, it was not possible to detect any issues in the corrugated tube and breathing bag.A leak test was performed, and the device passed.The complaint was not confirmed.No other analysis was performed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective action was taken because the complaint was not confirmed.
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Search Alerts/Recalls
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