MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-8.7-6.5-20; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35118
Medical Device Problem Codes	Collapse (1099); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.The actual complaint product was returned for evaluation.The investigation remains in progress.All information reasonably known as of 24 sep 2021 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).
Event or Problem Description
It was reported that "during surgical procedure on a patient's foot, the physician appreciated what seemed to be an airway obstruction.The [physician] initially assumed there to be a sputum plug, so they attempted to remove.The ett [endotracheal tube] would not clear, so they inserted a bronchoscope and found that the ett had kinked/collapsed in the patient's airway.They were unable to resolve the issue, so they extubated and reintubated with a new ett.There were no reports of patient harm and the procedure was able to be completed.".
Additional Manufacturer Narrative
The device history record for the reported lot number, cm1039002, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample endotracheal tube (ett) and a 10ml syringe were received with the opened original packaging.The ett was also seen having a medical tape near the blue vent connector prior to decontamination.The sample was cleaned and decontaminated, medical tape was removed leaving smeared of adhesive residue on the tube and the device was evaluated.The sample evaluation did not confirm the disposition, a root cause could not be determined.All information reasonably known as of 29-nov-2021 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, ORAL/NASAL MAGILL-8.7-6.5-20
• 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: 12530460
• Report Number: 3011270181-2021-00051
• Device Sequence Number: 4079580
• Product Code: BTR
• UDI-Device Identifier: 00609038351186
• UDI-Public: 00609038351186
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2026
• Device Model Number: 35118
• Device Catalogue Number: N/A
• Device Lot Number: CM1039002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 50 KG