FDA Adverse Event Death Summary report: N

Medline Industries, Inc.

MDR report key: 12821827 · Received November 16, 2021

Report

Report Number
1417592-2021-00204
Event Type
Death
Date Received
November 16, 2021
Date of Event
October 22, 2021
Report Date
November 16, 2021
Manufacturer
MEDLINE INDUSTRUIES LP
Product Code
BTR
UDI-DI
10080196726325
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IL, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1721487 Medline Industries, Inc. 7.5MM, HVLP,CUFFED,ET TUBE BTR MEDLINE INDUSTRUIES LP DYND43075 59220122559 10080196726325

Patients

Seq Age Sex Outcome Treatment
1 38 YR Male Death