SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C45091675D-NL |
Device Problem
Failure to Deliver (2338)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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B3: date of event, and d4: udi number are unknown.No information has been provided to date.D4: expiration date, and h4: manufacture date are not available based on the reported lot numbers.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 the dual limb circuit failed.The exact lot number is unknown (4341247 and 4364557 were reported).Patient involvement unknown.
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Manufacturer Narrative
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Other, other text: d10 - device available for evaluation and h6 - evaluation codes: updated
device evaluation: twenty unused devices, in their original packaging completely sealed, were returned for investigation.Visual inspection and functional testing found no faults or defects.The complaint could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective action is required as there is no information if the product leaks in the pre-check, which is listed in the instructions for use.
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Search Alerts/Recalls
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