MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 4MM, NASAL,PREFORMED,CUFFED,ET TUBE

Catalog Number	DYNJAANC40
Medical Device Problem Codes	Connection Problem (2900); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, "i encountered premature separation of a nasotracheal tube from its connector.The event was immediately recognized when end-tidal co2 abruptly dropped to zero.Because of the prompt actions, oxygen saturation remained > 97%, and the tube was reconnected, preventing patient harm.".
Additional Manufacturer Narrative
According to the facility, "i encountered premature separation of a nasotracheal tube from its connector.The event was immediately recognized when end-tidal co2 abruptly dropped to zero.Because of the prompt actions, oxygen saturation remained > 97%, and the tube was reconnected, preventing patient harm." no serious injury or medication intervention required, "the anesthesiologist identified the failure directly related to the etco2 reading." the dentist was forced to stop all activity and reconnect the device which disrupted workflow.No additional information at this time.The product has been requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: 4MM, NASAL,PREFORMED,CUFFED,ET TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23353522
• Report Number: 1417592-2025-00569
• Device Sequence Number: 9018760
• Product Code: BTR
• UDI-Device Identifier: 10080196503964
• UDI-Public: 10080196503964
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAANC40
• Device Lot Number: 59224113568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Female