MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TUBE,ENDOTRACH,HVLP CUFF,MURPHY,7.5MM

Catalog Number	DYNJAETC75
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Fitting Problem (2183)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "1 box of dynjaetc75 under lot 59224061677 is having difficulty with its connector component" and "the connector component is loose and cannot connect properly to the tube component.".
Additional Manufacturer Narrative
The account reported a "loose connector component," and the facility stated that after successful intubation, the hub/port "popped out just after intubation when connecting the ambu bag to ventilate" and "continued to pop out and not connect to et tube"; the facility also reported that a respiratory therapist cut her finger and the patient did not have ventilation until a third et tube was opened, with a delay in care "not spanning more than 3 minutes." no sample or photo was received for the investigation, and trending was reviewed with 0 additional reported complaints for this issue for the account in the past 24 months and 0 additional complaints reported for this product for this issue in the last 24 months.The investigation stated that complaints of this type are investigated based on the physical sample and use of the item, and medline was not able to confirm what may have caused the issue.The component disconnecting is an intentional design feature, 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.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: TUBE,ENDOTRACH,HVLP CUFF,MURPHY,7.5MM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50871399
• Report Number: 1417592-2026-49170
• Device Sequence Number: 13117999
• Product Code: BTR
• UDI-Device Identifier: 10888277689572
• UDI-Public: 10888277689572
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/23/2026

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: DYNJAETC75
• Device Lot Number: 59224061677
• 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: 03/07/2025
• Initial Report FDA Received Date: 09/23/2026
• 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