MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS MICROCUFF; MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL

Model Number	35113
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 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-jhc-24-00169.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.
Event or Problem Description
It was reported that on (b)(6) 2024, the microcuff tracheal tube (ett) was checked for leaks during use and a leak occurred; there was no reported injury to the patient.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 06 jun 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 (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
Correction: d1, d2, d4.The device history record for lot cm3205001, was reviewed and the product was produced according to product specifications.The actual sample from the reported event was returned for evaluation.During visual examination of the device, the balloon cuff did not exhibit any damage.However, when the inflation line/lumen was inspected under magnification (50x), multiple scratches were seen on the area of the inflation line/lumen in question.As well as, a jagged slanted opening.Testing of the sample revealed, an obvious leak, as the balloon cuff was unable to inflate.Additionally, when a colored liquid (water mixed blue dye) was flushed through the inflation valve, droplets of liquid were seen exiting out of the inflation line/lumen near the skive on the bi-lumen tube.The reported event could be confirmed, as reported.However, the root cause is undetermined.All information reasonably known as of 29 oct 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 (b)(4).This information is submitted pursuant to 21 cfr 803, 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 MICROCUFF
• Common Device Name: MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL
• 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19264527
• Report Number: 3011270181-2024-00050
• Device Sequence Number: 2569196
• Product Code: BTR
• UDI-Device Identifier: 00609038351131
• UDI-Public: (01)00609038351131(10)CM3205001
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024

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: 35113
• Device Catalogue Number: 35113
• Device Lot Number: CM3205001
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/31/2024; 10/09/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/10/2024; 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown