MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TUBE,ENDOTRACH,HVLP CUFF,MURPHY,7.0MM

Model Number	DYNJAETC70
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2023 the "tip of endotracheal tube pierced tonsil without significant resistance, leading to laceration and further surgery".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 the "tip of endotracheal tube pierced tonsil without significant resistance, leading to laceration and further surgery".Per the facility an ent surgeon was required to "cauterize the tonsil as the ett passed through the anterior aspect of the tonsil".Per the facility the procedure was able to be completed and the injury was discovered upon extubation of the patient.Sample requested to be returned for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Common Device Name: TUBE,ENDOTRACH,HVLP CUFF,MURPHY,7.0MM
• 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: 17315246
• Report Number: 1417592-2023-00288
• Device Sequence Number: 19842793
• Product Code: BTR
• UDI-Device Identifier: 10888277689565
• UDI-Public: 10888277689565
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/13/2023

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 Model Number: DYNJAETC70
• Device Catalogue Number: DYNJAETC70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/13/2023
• 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: Required Intervention
• Patient Sex: Unknown