FDA.reportPublic FDA data

MAUDE MDR 9581901

MDR report key
9581901
Report number
1722139-2020-00013
Event key
0
Event type
3
Date of event
2019-12-16
Date received
2020-01-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KRISTIN HARDESTY
Address
4314 ZEVEX PARK LANE SALT LAKE CITY UT 84123 US
Phone
801-801-8012
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BAG SET, 1200ML, ENFITCONNECTORENTERAL FEEDING SETMOOG MEDICAL DEVICES GROUPPIOINF1200-AINF1200-ANOT PROVIDEDR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-130

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED TO MMDG FOR EVALUATION. A DHR COULD NOT BE PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. BECAUSE THE DEVICE WAS NOT RETURNED, MMDG HAS BEEN UNABLE TO INVESTIGATE OR CONFIRM THE COMPLAINT. THIS REPORT WILL BE UPDATED IF THE DEVICE IS RETURNED TO MMDG.

D

Patient 1

THE INITIAL REPORTER STATES THAT THE PUMP ROLLER SEEMS TO BE WORKING BUT THE BAG DOESN'T DELIVER FORMULA. THEY ALSO STATED THAT "WHEN THEY SET UP A NEW BAG AT NIGHT THAT IT WORKS, BUT AFTER RINSING OUT THE BAG IN THE MORNING IT DOESN'T DELIVER". THEY ALSO STATED THAT THEY ARE USING KATE FARMS FORMULA. MMDG FOLLOWED UP WITH THE INITIAL REPORTER, WHO STATED THAT THE PATIENT WAS DOING WELL AFTERWARDS, AND HAD NOT HAD ANY ADVERSE EFFECTS. (B)(4).