SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA 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 04/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Udi section is unknown, no information is available to date.D4: expiration date and h4: manufacture date are not available based on the reported lot number.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 during the pre-use check, leakage of air from the product was observed.No adverse patient effects were reported by the customer.It has been reported that there is no additional information available for this event.
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Manufacturer Narrative
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Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received without original packaging.The device was visually inspected without magnification at a distance of 12 to 16 inches and normal conditions of illumination, and it was confirmed there was a little hole (perforation).A leak test was detected during functional testing confirming the complaint.A root cause was due to the production operator not following manufacturing procedures.A device history record (dhr) review showed no issues or non-conformances during the manufacturing of the reported lot number.Aware ness has been made to production personnel and this issue will monitored and further actions taken accordingly.
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Search Alerts/Recalls
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