A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 08 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 inc.Complaint database and identified as complaint (b)(4).
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Avanos medical inc.Received a single report that referenced ten different incidences, which were associated with separate units, involving different patients.This is the fifth of ten reports.Refer to 8030647-2020-00104 for the first report.Refer to 8030647-2020-00105 for the second report.Refer to 8030647-2020-00106 for the third report.Refer to 8030647-2020-00107 for the fourth report.Refer to 8030647-2020-00109 for the sixth report.Refer to 8030647-2020-00110 for the seventh report.Refer to 8030647-2020-00111 for the eighth report.Refer to 8030647-2020-00112 for the ninth report.Refer to 8030647-2020-00113 for the tenth report.It was reported that the flex tube (flex connector) disconnected from the closed suction system.Product was in use for one to three days.No patient injury was reported.
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