MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 7.0MM, HVLP,CUFFED,ET TUBE

Catalog Number	DYND43070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, the "ett cuff failure" was noted prior to prepping the patient for a surgical procedure.Per the customer "the ett was removed and replaced." the customer said that "the cuff of the second ett was noted to have a significant leak" after the patient was prepped and draped.The customer reported that "the ett was again replaced but with a different [manufacturer's] ett" and the surgical procedure was "completed without issue." the customer said that the "balloons were tested prior to intubation by the crna." the customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2025, the "ett cuff failure" was noted prior to prepping the patient for a surgical procedure.

• Common Device Name: 7.0MM, HVLP,CUFFED,ET TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23633775
• Report Number: 1417592-2025-00649
• Device Sequence Number: 10379948
• Product Code: BTR
• UDI-Device Identifier: 10080196996391
• UDI-Public: 10080196996391
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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 Catalogue Number: DYND43070
• Device Lot Number: 59225030692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 74 KG