Model Number TBT02100ST |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units.This is the first of two reports.Refer to 2026095-2022-00014 for the second report.It was reported there was an incident of possible catheter shearing upon removal.There was no report of medical intervention.The date of surgery (b)(6) 2021.Additional information received 08mar2022 reported the patient returned to the hospital to have the catheter removed and it appeared to be not removeable; it was extracted with a piece of the retained catheter left behind.The patient returned for a follow up appointment and it was noted that the patient did not experience any known complications or infection; the patient will continue to follow-up as planned.
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 15 mar 2022 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 event reported but is relaying the information that was 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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Root cause could not be determined.The device history record for lot 30163419 was reviewed and the product was produced according to product specifications.All information reasonably known as of 07 may 2022 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 event reported but is relaying the information that was 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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