Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2022 |
Event Type
Injury
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Event Description
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It was reported that while assisting with a routine tracheostomy tube change for a patient, (bivona flextend 5.0mm tube) the tube being placed was on it's fourth usage.When the tube was placed into the patient's stoma the introducer became stuck, attempted to remove it unsuccessfully.This resulted in an emergency tube which was traumatic for the patient.
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Event Description
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It was reported that while assisting with a routine tracheostomy tube change for a patient, (bivona flextend 5.0mm tube) the tube being placed was on it's fourth usage.When the tube was placed into the patient's stoma the introducer became stuck, attempted to remove it unsuccessfully.This resulted in an emergency tube which was traumatic for the patient.
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Manufacturer Narrative
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Other, other text: b5: additional information received 08-mar-2022: product and packing was not retained.Item and lot numbers are not known.- product will not be returned for investigation.H6: event problem and evaluation codes: updated.H10: device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
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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 product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Search Alerts/Recalls
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