Device Problems
Degraded (1153); Problem with Sterilization (1596)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that five (5) trachs breakdown after being sterilized 1-2 times.Ifu sterilization had been followed.No patient injury was reported.
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Manufacturer Narrative
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Other text: additional information was received via a customer response email on 04-nov-2022.No patient involvement.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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Event Description
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Additional information was received via a customer response email on 04-nov-2022: there is no additional information to share as the breakdown in the tracheostomy tube was identified prior to patient use.
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Manufacturer Narrative
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Other text: h6: event problem and evaluation codes: updated.H10: no lot number was provided; therefore, device history record review could not be performed.A product sample and six photos were received for evaluation.Visual and functional testing was performed.Visual inspection found no damaged could be detected.Functional testing found the cuff inflated successfully; the complaint was not confirmed.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.
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Search Alerts/Recalls
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