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

Model Number	35215
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 03 dec 2024 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 comp (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.
Event or Problem Description
It was reported, there was no suction (during use), it was discovered kinking had occurred in [the] oral pharynx; the patient was reintubated.It was additionally reported, a ¿non-serious¿ other event(s) occurred; there was no reported injury.Additional information received 07nov2024 reported, it is unknown how long the endotracheal tube (ett) was in place prior to the tube kinking.
Additional Manufacturer Narrative
The actual sample, from the reported event was returned; the sample was received with a note which stated, ¿cuff torn at intubation¿ (which was not reported prior to receipt of the sample).The sample was evaluated for the reported issue of ¿bent/kink¿.No evidence of kinking/crimping were found, nor were there any other damages noted to the tubing; as no issues, related to the report of bent/kink were observed on the device the reported failure was not reproduced in the lab and the root cause could not be determined.During evaluation, what appeared to be a scratch was observed on the tubing, which extended from the lateral black line proximal to the cuff down through the proximal cuff collar.When examined under magnification, the cuff exhibited a radial tear near the proximal end.The tear, which was noted with the sample return was confirmed; however, the root cause could not be determined.The device history record for lot cm3230003 was reviewed and the product was produced according to product specifications.All information reasonably known as of 10 jan 2025 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.

• Brand Name: AVANOS, VAP MICROCUFF ENDOTRACHEAL TUBES
• Common Device Name: MICROCUFF ADULT ENDOTRACHEAL TUBE
• 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, edificio 16; managua, managua
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20835761
• Report Number: 3011270181-2024-00126
• Device Sequence Number: 4070110
• Product Code: BTR
• UDI-Device Identifier: 00609038352152
• UDI-Public: (01)00609038352152(10)CM3230003(17)280818(11)230818
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K113333
• 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): 01/13/2025

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 Model Number: 35215
• Device Catalogue Number: 35215
• Device Lot Number: CM3230003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• 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: 11/03/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown