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

Catalog Number	DYNJAETC75
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2025 "patient was intubated successfully with 7.5 et tube, the hub/port at end of tube that has the standard hard plastic piece that connects to ambu bag or ventilator circuit popped out just after intubation when connecting the ambu bag to ventilate".
Additional Manufacturer Narrative
According to the facility on (b)(6)2025 "patient was intubated successfully with 7.5 et tube, the hub/port at end of tube that has the standard hard plastic piece that connects to ambu bag or ventilator circuit popped out just after intubation when connecting the ambu bag to ventilate".Per the facility "when respiratory therapist grabbed the hub, attempted to place back on et tube, bodily fluids were coming out of et tube and unable to ventilate the patient".Per the facility "when respiratory attempted to place back et tube hub/connector piece, it continued to pop out and not connect to et tube".Per the facility multiple et tubes packages were opened to find a "hub/connection piece" that fit.Per the facility during this time the patient was receiving compressions/cpr and there was a delay in patient care "not spanning more than 3 minutes".Per the facility the patient was transferred to the icu.No additional information was provided.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: TUBE,ENDOTRACH,HVLP CUFF,MURPHY,7.5MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21724220
• Report Number: 1417592-2025-00146
• Device Sequence Number: 18514568
• Product Code: BTR
• UDI-Device Identifier: 10888277689572
• UDI-Public: 10888277689572
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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
• Device Catalogue Number: DYNJAETC75
• Device Lot Number: 59224061677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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 Sex: Unknown