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

Catalog Number	DYND43080
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they had to put 80+cch2o into the cuff in order to inflate it.
Additional Manufacturer Narrative
According to the facility, the patient was intubated without difficulty but in order to get a seal the therapist had to add (b)(6); there was no injury or medical intervention required and the patient has since been extubated.A photo was received for the investigation, and the sample consisted of two photographs of the packaging; the actual sample used in the procedure was not available, and trending found 0 additional reported complaints for this issue for the account in the past 24 months.Due to the actual sample used in the procedure not available, medline was not able to confirm the quality issue with the 8.0mm endotracheal tube, and the cause was documented as sample required to determine cause.This complaint has been provided to the component manufacturing facility for further evaluation, and the quality team 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: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803591
• Report Number: 1417592-2026-43512
• Device Sequence Number: 13399010
• Product Code: BTR
• UDI-Device Identifier: 30080196726336
• UDI-Public: 30080196726336
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Device Lot Number: 59221030404
• 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: 03/07/2024
• Initial Report FDA Received Date: 09/17/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown