MAUDE MDR 7591254

MDR report key
7591254
Report number
7591254
Event key
0
Event type
3
Date of event
2018-05-16
Date received
2018-06-12
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CORFLO ULTRA NG FEEDING TUBETUBE, FEEDINGHALYARD HEALTH, INC.FPD20-7431AIV220-7431AIV278691R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-120

Event Narratives#

N

Patient 1

D

Patient 1

DOBHOFF FEEDING TUBE INSERTED AND PLACEMENT CONFIRMED. WHEN NURSE ADMINISTERED MEDICATIONS, THEY CAME OUT OF A SLIT/HOLE IN THE TUBING. TUBING REMOVED; NEW TUBING INSERTED. THE PATIENT WAS NOT HARMED.