Catalog Number 100/563/080 |
Device Problems
Entrapment of Device (1212); Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/21/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a percutaneous tracheostomy.The procedure was not successful and was aborted.Two days later the patient was taken to the operating room for a surgical tracheostomy.At the start of this procedure the surgeon could feel a hard piece of plastic in the patients neck palpating into the previous surgical scar, and found a plastic cannula (from previous perc tracheostomy attempt) in the neck and removed it.Surgical tracheostomy was then performed without further issues.Patient attended operating room procedure for surgical tracheostomy after failed percutaneous tracheostomy.The retained object was successfully removed from the patient's neck two days following insertion.
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Manufacturer Narrative
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This 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.A review was performed on the returned piece which found that only the 14g cannula was returned from the customer.The root cause of the reported issue was found to be poor user handling.No corrective actions were documented.
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Search Alerts/Recalls
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