SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number 670003 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A product sample was received and is awaiting evaluation and 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.Protocol number and udi are unknown, no product information has been provided to date.Device manufacturing date and device expiration date are unknown, no product information has been provided to date.
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Event Description
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It was reported that during the pre-use air leak check of three devices, leakage was detected in all of them.Also, one (1) had a crack in the connector.No patient injury was reported.No additional information is available.
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Manufacturer Narrative
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Other text: e4 is unknown, no information provided to date., corrected data: e4 (updated in h10).
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Manufacturer Narrative
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Other text: no lot number was provided; therefore, device history record review could not be performed.Three (3) product samples and seven (7) pictures were received for evaluation.Visual and functional testing were performed.Visual inspection of the pictures observed a top view of 3 bags which is present tears and damaged on different sections.Visual inspection of the samples were torn.Functional testing found the failure reported could not be reproduced in the manufacturing process.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.Therefor the damage (broken) was after the product left manufacture facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.
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Search Alerts/Recalls
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