Model Number 42-9368 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problems
Aspiration/Inhalation (1725); Respiratory Tract Infection (2420); Cough (4457)
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Event Date 03/08/2023 |
Event Type
Injury
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Event Description
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It was reported that the nurse flushed the nasogastric (ng) tube under gravity and the patient started violently coughing watery sputum out of his tracheostomy.It appeared that he may be aspirating on the water, so the nurse immediately stopped to investigate.When the ng tube was subsequently removed, a 2cm length had dilated and split around the 45cm mark.It is unclear when this happened and how much feed or fluid had leaked into his lungs.The patient remained unwell 24 hours later and needed higher o2 requirements.Medical treatment reported includes antibiotics and chest physio.The tube had been in use for 28 days.Per additional information received on 10mar2023, ¿the patient remains unwell with a lower respiratory tract infection for which he¿s prescribed antibiotics.¿ per additional information received on 20mar2023, ¿he [the patient] seems to have deteriorated clinically in the last few days with another chest infection.He¿s now on end of life care.¿.
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Manufacturer Narrative
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The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Manufacturer Narrative
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H6: investigation conclusion: appropriate code not available: unintended use error caused or contributed to event.The subject sample provided was evaluated, confirming a black and pink discoloration through the tube.Also, the tubing appeared to have expanded to form a balloon shape which burst axially, causing the tube to be open and unable to use.When manually pressing the tubing back together, there were thin layers of the material noticed on the ballooned portion of the tube.The incident was confirmed as reported.The root cause of the reported issue could not be conclusively determined.However, this seems to be a user-related problem since, per the instructions for use (ifu), vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 02 may 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Search Alerts/Recalls
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