MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TUBE, ENDOTRACHEAL,CUFF, STYLET, 7.5MM

Catalog Number	DYNJAETC75S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 after intubation, it was discovered that the "cuff" on the et tube was leaking causing ineffective ventilation of the patient.The customer reported the leak was confirmed by submerging the et tube in water.The customer reported the patient was re-intubated as a result of the reported issue.The customer reported the patient did not have any "issues" related to the reported event.The customer did not report any serious injury related to the reported event.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 again.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 after intubation, it was discovered that the "cuff" on the et tube was leaking causing ineffective ventilation of the patient.

• Common Device Name: TUBE, ENDOTRACHEAL,CUFF, STYLET, 7.5MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21697943
• Report Number: 1417592-2025-00143
• Device Sequence Number: 15761636
• Product Code: BTR
• UDI-Device Identifier: 10888277724808
• UDI-Public: 10888277724808
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/26/2025

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: DYNJAETC75S
• Device Lot Number: 59224082493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 126 KG