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

Model Number	35117
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	05/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18 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.
Event or Problem Description
It was reported, the endotracheal tube (ett) was inserted for emergency surgery on the patient who was a known asthmatic and who was suspected of having testicular torsion.The intubation was reportedly "straightforward".Five (5) minutes into the case, increasing airway pressures were noted as well as a change in the end tidal carbon dioxide trace, which was thought to be acute bronchospasm [and was treated as such]; the patient was reported to be "very" difficult to ventilate.The surgery was completed and the pediatric retrieval team became involved in order to stabilize the patient, who was transferred to the nearest pediatric critical care unit.Prior to transfer of the patient, bronchoscopy down the tube was attempted; however, the ett was found to be significantly kinked just above the patient¿s vocal cords.It was additionally reported, there had been no manipulation of the patient¿s head during the case.Additional information received 06jun2024 the patient required reintubation; the patient was discharged from the hospital 24 hours later.
Additional Manufacturer Narrative
The device history record for lot cm3165002 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation; however, photographs of the alleged device were provided.Review of the images provided confirmed the event as reported, tube//bent/kinked; however, without a sample to perform functional evaluation the root cause could not be determined.All information reasonably known as of 04 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 (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
• Common Device Name: MICROCUFF 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: 19571197
• Report Number: 3011270181-2024-00070
• Device Sequence Number: 19873783
• Product Code: BTR
• UDI-Device Identifier: 00609038351179
• UDI-Public: (01)00609038351179(10)CM3165002(17)280614(11)230614
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/04/2024

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 Model Number: 35117
• Device Catalogue Number: 35117
• Device Lot Number: CM3165002
• Was Device Available for Evaluation?: No
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 50 KG