MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 8.0MM, HVLP,CUFFED,ET TUBE

Catalog Number	DYND43080
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿hard sharp end of endotracheal tube.¿.
Additional Manufacturer Narrative
The account reported that during routine intubation for surgery, placement of a lubricated endotracheal tube resulted in minor glottic bleeding due to a hard sharp end of the endotracheal tube, and this was more than anticipated given the ease of intubation.No sample or photo was received for investigation, finished good production records could not be reviewed since a lot number was not provided, and component trending was reviewed with 0 additional reported complaints for this issue for the last 24 months.Based on the complaint details and investigation, the complaint is not confirmed, and the investigation was limited without receipt of the lot number, a physical sample, or detailed photographic evidence from the customer.The sample was required to determine cause, and the division will monitor this issue for trending purposes.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: 8.0MM, HVLP,CUFFED,ET TUBE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931634
• Report Number: 1417592-2026-52930
• Device Sequence Number: 9498629
• Product Code: BTR
• UDI-Device Identifier: 10080196726332
• UDI-Public: 10080196726332
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: DYND43080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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