FDA Adverse Event Summary report: N

NEOBAR

MDR report key: 2280222 · Received September 23, 2011

Report

Report Number
2280222
Date Received
September 23, 2011
Date of Event
September 8, 2011
Report Date
September 23, 2011
Manufacturer
NEOTECH PRODUCTS, INC.
Product Code
CBH
Report Source
User Facility report
Reporter Location
IA, US

Narratives

Description of Event or Problem · 1

PATIENT WAS INTUBATED WITH A NEOBAR HOLDING ENDOTRACHEAL TUBE (ETT) IN PLACE. RN HAD JUST PLACED A NEW NEOBAR, BUT WITHIN MINUTES THE NEOBAR BECAME UNSTUCK FROM THE FACE AND THE ETT WAS NEARLY LOST. CONTRIBUTING FACTORS MAY HAVE BEEN PATIENT WAS SWEATY AND HAD A LOT OF SECRETIONS. NO PATIENT HARM RESULTED FROM THIS EVENT - WE ARE REPORTING THIS SOLELY BASED ON POTENTIAL FOR PATIENT HARM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NEOBAR DEVICE, FIXATION, TRACHEAL TUBE CBH NEOTECH PRODUCTS, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 3 MO