MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13222
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Tachycardia (2095); Low Oxygen Saturation (2477)
Date of Event	01/14/2022
Type of Reportable Event	Death
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units.This is the second of two reports.Refer to 9611594-2022-00013 for the first report.Additional information received, (b)(6) 2022 reported that the patient was admitted to the hospital with a diagnosis of covid and was being held in the emergency department on bipap to maintain oxygenation and other care needs.It was reported that the patient continued to decline and due to no ventilators being available at the hospital the patient was transferred to a new facility.Upon arrival at the new facility the patient was reported to be unconscious, had severe tachycardia, tachypnea and an oxygen level of 39%.After an unsuccessful attempt to intubate the patient, due to the endotracheal (et) tube cuff not inflating, the patient was successfully intubated on the third attempt.Additionally, a bag/mask [was used] until a new et tube was available.It was reported that the patient continued to decline and expired, the patient was dnr status (do not resuscitate).
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 20060236 was reviewed and the product was produced according to product specifications.Root cause could not be determined.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.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.H3 other text : device not returned.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 20060236 was reviewed and the product was produced according to product specifications.Root cause could not be determined.All information reasonably known as of 16 feb 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.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).
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units.This is the second of two reports.Refer to 9611594-2022-00013 for the first report.Additional information received, (b)(6) 2022 reported that the patient was admitted to the hospital with a diagnosis of covid and was being held in the emergency department on bipap to maintain oxygenation and other care needs.It was reported that the patient continued to decline and due to no ventilators being available at the hospital the patient was transferred to a new facility.Upon arrival at the new facility the patient was reported to be unconscious, had severe tachycardia, tachypnea and an oxygen level of 39%.After an unsuccessful attempt to intubate the patient, due to the endotracheal (et) tube cuff not inflating, the patient was successfully intubated on the third attempt.Additionally, a bag/mask [was used] until a new et tube was available.It was reported that the patient continued to decline and expired, the patient was dnr status (do not resuscitate).

• Brand Name: MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13545983
• Report Number: 9611594-2022-00014
• Device Sequence Number: 19379874
• Product Code: BTR
• UDI-Device Identifier: 00609038132228
• UDI-Public: 00609038132228
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 13222
• Device Catalogue Number: N/A
• Device Lot Number: 20060236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Male