MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-TUBE,ENDOTRACHEAL,SUBG,7.5

Catalog Number	DYNJ18875
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported that the pilot ballon and extended tubing fell off while the patient was intubated; the cuff did indeed deflate and the patient was successfully extubated without harm to the patient.Medline quality received one unit in used condition without the original packaging, found the markings at the "18" and "20" graduation marks appeared to have rubbed off and are barely visible, and found the inflation tubing was not connected to the main et tube; at the base of the tube there was a yellow discoloration but no tearing or signs of breakage, and the inflation tubing could be placed back into where it would attach to the main et tube and freely come out as if the tubing fell out but did not break off.The returned sample confirmed the reported detachment, and based on the sample and complaint details the root cause is considered to be a vendor product issue relating to the manufacturing process; the vendor performed testing of the inflation tubing and found no issue in retention stock but stated that the most likely root cause was insufficient bonding.This complaint has been provided to the 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.
Event or Problem Description
It was reported that "the entire pilot balloon fell off while the patient was intubated.The cuff did indeed deflate.".

• Brand Name: MEDLINE
• Common Device Name: DBD-TUBE,ENDOTRACHEAL,SUBG,7.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50902593
• Report Number: 1417592-2026-51341
• Device Sequence Number: 16128819
• Product Code: BTR
• UDI-Device Identifier: 20888277652702
• UDI-Public: 20888277652702
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K110269
• 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): 09/25/2026

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: DYNJ18875
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/22/2022
• 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: 02/17/2024
• Initial Report FDA Received Date: 09/25/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown