SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Model Number CP120I/200/004 |
Device Problems
Leak/Splash (1354); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other, other text: d4: udi, expiration date, g5: no 510k as item is not sold in us, h4 - no information received to date.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 leaks were found during the pre-test.
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Manufacturer Narrative
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Device evaluation: one device and five (5) photos were returned for investigation.Upon visual inspection, a tear was found in the breathing bag confirming the customer complaint.The device was functionally tested where it was found that the hole did not affect the function of the bag.The customer found this issue prior to use.Further inspection showed that the hole was created by molding during the suppliers manufacturing process.Production personnel have been informed of this issue and will continue to monitor this issue.Device history review of the reported lot number shows no non-conformities during the manufacturing process.
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Search Alerts/Recalls
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