The actual complaint product was not returned 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) 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).
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Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the fourth of four reports.Refer to 9611594-2022-00022 for the first report.Refer to 9611594-2022-00023 for the second report.Refer to 9611594-2022-00024 for the third report.It was reported a perforation occurred, with the corflo bolus feed ng tube.The event occurred while the patient was in the intensive care unit (icu).Additional information received on (b)(6) 2022 reported that there was a perforation and there was no medical intervention.Additional information received on (b)(6) 2022, it was reported that four (4) nurses, (a registered nurse (rn) of 1 year, an rn of 22 years, an rn of 10 years and an rn of 44 years), over two shifts, made multiple attempts to insert the soft ng tube.Afterwards, the pnuemothorax was discovered.The patients current condition is unknown.
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