MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35117
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is reported to be available but has not been returned.A review of the device history record is in-progress.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, inc.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.Device not returned.
Event or Problem Description
Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 3011270181-2022-00093 for the second event.Refer to 3011270181-2022-00094 for the third event.It was reported that the endotracheal tube kinked, causing inadequate ventilation and not possible to pass a suction catheter through.Patient was intubated, but adequate ventilation could not be established.The patient was reported to be on ecmo (extracorporeal membrane oxygenation) however, it is unknown if the reported issue is why the patient is on ecmo.Additional information received 14-dec-2022 stated the endotracheal tube [ett] was in place 6-hours prior to the ett kinking.The patient is currently on extracorporeal life support (ecls).The tube was not altered in anyway prior to the reported incident occurring.The ett was suctioned once during this time.The ett was secured with an etad (endotracheal tube attachment device) and the position was not changed during this time.The patient was changed to hfov (high-frequency oscillatory ventilation) from conventional ventilation for approximately 70-minutes due to increasing ventilatory support as patient was not being ventilated effectively with the unknown kinked ett.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 27-jan-2023 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).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.
Additional Manufacturer Narrative
The device history record for the reported lot number, cm 0267001, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.A physical sample was provided.The reported failure was not observed in the lab on the returned et (endo-tracheal) tube device.Root cause could not be determined.All information reasonably known as of 02-nov-2023 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).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.

• Brand Name: MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): COMMAND MEDICAL NICARAGUA SA; km 12.5 carretera norte; parque industrial las mercedes; managua, managua
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16069669
• Report Number: 3011270181-2022-00092
• Device Sequence Number: 6294875
• Product Code: BTR
• UDI-Device Identifier: 00609038351179
• UDI-Public: 00609038351179
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2025
• Device Model Number: 35117
• Device Catalogue Number: N/A
• Device Lot Number: CM0267001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/04/2023; 10/18/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/30/2023; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 28 KG