MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 7.5MM, HVLP,CUFFED,ET TUBE

Catalog Number	DYND43075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the patient was requiring intubation during a "code blue" on (b)(6) 2024 and the "ett" cuff was leaking.
Additional Manufacturer Narrative
According to the customer, the patient was requiring intubation during a "code blue" on (b)(6) 2024 and the "ett" cuff was leaking.The customer reported that after the incident occurred the "ett" was replaced.The customer reported after the tube was replaced the patient "was stable" and there were "no injuries".The customer reported the patient did not experience "hypoxia" or "difficulty breathing" related to the reported incident.The customer reported there was no serious injury or follow-up care needed related to the reported incident.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: 7.5MM, HVLP,CUFFED,ET TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19509932
• Report Number: 1417592-2024-00640
• Device Sequence Number: 3394319
• Product Code: BTR
• UDI-Device Identifier: 30080196726329
• UDI-Public: 30080196726329
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: DYND43075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG