Catalog Number FT15LN90NSC861N |
Device Problems
Defective Device (2588); Infusion or Flow Problem (2964)
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Patient Problems
Respiratory Distress (2045); Extubate (2402); Patient Problem/Medical Problem (2688)
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Event Date 02/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
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Event Description
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It was reported that a portex® bivona® custom adult tracheostomy tube was defective and possibly caused airflow restriction during use with a patient.The device was inserted in the patient when the patient was in respiratory distress.The cuff patency was tested by the patient's mother prior to use.The cuff was filled with air.An emergency tracheostomy tube change was conducted, which was reported to have resolved the issue.No permanent injury was reported.
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Event Description
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It was further reported that patient received an emergent tracheostomy tube change as the patient was not ventilating at the time of the event.Additionally, it was reported that the patient did desaturate; however, the exact level was unknown.
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Manufacturer Narrative
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A review of the device history record was performed, and no discrepancies were noted.Upon receipt of the returned product specimen for device evaluation, it was visually examined.One used tracheostomy tube was received.Visual examination revealed no non-conformities.There were also no discrepancies with respect to dimensional and curvature inspection.Functional testing for leakage was performed and found no leak.The reported issue could not be replicated.Upon consultation with the smiths medical respiratory therapist in-residence, further analysis of the reported information and the device again revealed no non-conformities.This clinical expert hypothesized that the reported issue is not uncommon in cases of tracheomalacia.It is possible that a unique physiological condition was present in this particular patient that may have led to respiratory distress and was unrelated to the device itself.While no definitive root cause could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
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Search Alerts/Recalls
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