Model Number 101/860/080CZ |
Device Problem
Gel Leak (1267)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
malfunction
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Event Description
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Information received a smiths medical tracheostomy|pvc - portex tubes bluselect had leaking.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: investigation completed on a smiths medical bluselect 8.0, suctionaid, cuffed.Sub-assy was received for investigation without its original packaging.The manufacturing is reviewed and cuff passed 100 percent prior to leaving facility.The most like cause is believed incident occurred after leaving manufacturing and during placement.Each cuff shall be also tested by customer prior use as per instruction for use as10006183-004 rev.102, point 11.2: "check the integrity of the cuff and inflation system prior to insertion.".
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Event Description
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Device investigation completed and summary in h 10.
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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# (b)(4).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.It was found that it was not even possible to inflate cuff due to leaks.The root cause of the reported issue was found to be due to fact that cuff leak was observed after placement it is the most probable that reported failure occurred during tracheostomy procedure or during use.No actions were taken.
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Search Alerts/Recalls
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