SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Model Number 101/860/080CZ |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.A hole was detected in the cuff.The root cause of the reported issue was found to be a hole which was causing reported leakage of inflation system.Actions were taken to mitigate the reported issue: there is an open nonconforming report (ncr) which is focused on reduction of possibility of cuff tear during manufacturing process.
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Event Description
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It was reported that during the pre-use check, the customer noticed the cuff was unable to be inflated.No patient injury was reported.
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Search Alerts/Recalls
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