MAUDE Adverse Event Report: Medline Industries, LP Medline; ENDOTRACH TUBE, CUFFED, FLEX, 8.0MM

Catalog Number	DYNJAFLEX80
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: ENDOTRACH TUBE, CUFFED, FLEX, 8.0MM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: martin posada ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50046753
• Report Number: 1417592-2026-07892
• Device Sequence Number: 13420853
• Product Code: BTR
• UDI-Device Identifier: 10197344104772
• UDI-Public: 10197344104772
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

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
• Device Catalogue Number: DYNJAFLEX80
• Device Lot Number: 51124120038
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/20/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown