SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Model Number 101/860/070 |
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 11/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that after the customer changed the tube to a new one for regular replacement, air pressure of the cuff decreased in about four (4) hours.After that, he put air in the cuff several times, but its air pressure lowered again.So he changed it to another new one.No patient injury reported.
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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.
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Manufacturer Narrative
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Manufacturing device history record review was not performed because no fault was found.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the sample appeared to be in good condition.Functional testing found that after 12 hours of the inflation test, the cuff was still fully inflated.Device passed all functional testing, unable to replicate the reported issue.No problem found.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.
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