MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TUBE,ENDOTRACHEAL,SUBG,7.5

Catalog Number	DYNJ18875
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the patient required "insertion/placement of ett" for "respiratory distress", and the cuff "did not inflate to provide securement in the trachea" when "10cc of air" was used to fill the cuff.The customer reported a new tube was required to be inserted.The customer reported the patient did not experience hypoxia or difficulty breathing related to the reported issue.The customer reported the patient had "cardiac arrest" post intubation however, it "was not related to the intubation per md".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.
Event or Problem Description
According to the customer, on (b)(6) 2024 the patient required "insertion/placement of ett" for "respiratory distress", and the cuff "did not inflate to provide securement in the trachea" when "10cc of air" was used to fill the cuff.

• Common Device Name: TUBE,ENDOTRACHEAL,SUBG,7.5
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19392278
• Report Number: 1417592-2024-00618
• Device Sequence Number: 20771816
• Product Code: BTR
• UDI-Device Identifier: 20888277652702
• UDI-Public: 20888277652702
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: DYNJ18875
• Device Lot Number: 59223020155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/24/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-24-043
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown