Avanos medical inc.Received a single report that referenced at least two different incidences, which were associated with separate units, involving different patients.This is the first of two reports.Refer to 8030647-2020-00081 for the second report.It was reported that the suction catheter keeps disconnecting from the patient.During a 12 hours shift the nurse estimates that the same device disconnects 5-10 times.No patient injury.Additional information requested but not yet provided.
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Per review it was found that the initial report filed for this complaint was submitted under the manufacturer report number 8030647-0020-00080, containing a typo in the year.Therefore a new initial mdr has been submitted to replace the initial report report, under the corrected manufacturer report number 8030647-2020-00080.Any future follow ups will be filed under the corrected report number 8030647-2020-00080, and no further reports will be filed under 8030647-0020-00080.All information reasonably known as of 15 dec 2020 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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