MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP Medline Industries, Inc.; 7.5MM, HVLP,CUFFED,ET TUBE

Model Number	DYND43075
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/22/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was reported that during an emergent placement (during an in-flight cardiac arrest) a patient was intubated with a 7.5mm endotracheal tube.Intubation was completed and the cuff was inflated with 7ml of air.The crew noted that the cuff would not stay inflated, bougie was placed and the tube was exchanged successfully however the patient ultimately passed away.The sample was not returned to the manufacturer for evaluation.No additional information is available.Due to the reported incident and 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
It was reported that during an emergent placement (during an in-flight cardiac arrest) a patient was intubated with a 7.5mm endotracheal tube.Intubation was completed and the cuff was inflated with 7ml of air.The crew noted that the cuff would not stay inflated, bougie was placed and the tube was exchanged successfully however the patient ultimately passed away.

• Brand Name: Medline Industries, Inc.
• Common Device Name: 7.5MM, HVLP,CUFFED,ET TUBE
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12821827
• Report Number: 1417592-2021-00204
• Device Sequence Number: 5696393
• Product Code: BTR
• UDI-Device Identifier: 10080196726325
• UDI-Public: 10080196726325
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND43075
• Device Catalogue Number: DYND43075
• Device Lot Number: 59220122559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 117 KG