MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; ENDOTRACH TUBE, CUFFED, FLEX, 8.0MM

Catalog Number	DYNJAFLEX80
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A slow leak in the pilot balloon happened in the operating room (or).
Additional Manufacturer Narrative
It was reported that the pt arrived from or with 7.5 endotracheal tube.Anesthesia made rt and team aware that a slow leak in the pilot balloon happened in the or.They did a tube exchange and they believe the new ett had a small leak when arriving to the unit.Confirmed through the next couple of hours when the balloon deflated.Tube exchange/reintubation.Tube was exchanged and the patient did not experience sequela from the event.The defect was on the "main" balloon at the junction of the pilot balloon, not the pilot balloon itself.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Brand Name: MEDLINE
• Common Device Name: ENDOTRACH TUBE, CUFFED, FLEX, 8.0MM
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; nuevo laredo 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25451383
• Report Number: 3004122598-2026-00024
• Device Sequence Number: 10450467
• Product Code: BTR
• UDI-Device Identifier: 10197344104772
• UDI-Public: 10197344104772
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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 Catalogue Number: DYNJAFLEX80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White