FDA.reportPublic FDA data

MAUDE MDR 6409116

MDR report key
6409116
Report number
1018233-2017-01127
Event key
0
Event type
3
Date received
2017-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
AMY GRAVLEY
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE, 7.0AGENTO ET TUBEBARD SHANNON LIMITED -3005636544BTR500370(01)00801741067280Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-160

Event Narratives#

N

Patient 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

D

Patient 1

IT WAS REPORTED THAT THERE WAS A DEFECT WITH THE ET TUBE. IT WAS LATER REPORTED THAT THERE WAS A HOLE IN THE TUBING CAUSING VOLUME LOSS ON THE VENTILATOR. THE PATIENT WAS ALLEGEDLY WEANED OFF OF THE ETT SUCCESSFULLY AFTER TWO DAYS OF USE, AS HE WAS READY TO COME OFF OF THE VENTILATOR. NO PATIENT INJURY WAS REPORTED.