FDA.reportPublic FDA data

MAUDE MDR 6058006

MDR report key
6058006
Report number
1722139-2016-00587
Event key
0
Event type
3
Date of event
2016-09-27
Date received
2016-10-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
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, 0500ML, WITH ENFIT CONNECTORENTERAL FEEDING SETMOOG MEDICAL DEVICES GROUPPIOINF0500-AINF0500-ANOT PROVIDEDR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-260

Event Narratives#

N

Patient 1

THE DEVICE IN QUESTION IS NEW TO THE MARKET. IT IS ONE OF THE FIRST ENTERAL BAG/ADMINISTRATION SETS TO INCORPORATE THE NEW ENFIT CONNECTORS, WHICH WERE SPECIFICALLY DESIGNED TO BE EXCLUSIVELY COMPATIBLE WITH ENTERAL FEEDING TUBES. (B)(4) IS ONE OF THE FIRST COMPANIES TO BRING ENFIT CONNECTOR-CONTAINING PRODUCTS TO THE MARKET, BUT OTHERS WILL SHORTLY FOLLOW SUIT. IN FACT, THE ENFIT CONNECTORS ARE SCHEDULED TO BECOME THE INDUSTRY STANDARD OVER THE COURSE OF 2015, WITH THE OLDER CHRISTMAS-TREE-STYLE CONNECTORS SCHEDULED TO BE PHASED OUT OF THE INDUSTRY BY EARLY 2016. SINCE THE INTRODUCTION OF THE NEW ENFIT CONNECTOR-CONTAINING ENTERAL FEEDING SETS EARLIER THIS YEAR, (B)(4) HAS RECEIVED A NUMBER OF COMPLAINTS ABOUT THE NEW SETS, THE MOST COMMON BEING THAT THEY LEAK IN THE VICINITY OF THE PURPLE ENFIT CONNECTOR PIECE AND THE WHITE TRANSITIONAL STEPPED CONNECTOR. NO INJURY TO A PATIENT WAS ALLEGED IN THIS PARTICULAR COMPLAINT, AND (B)(4) HAS NOT RECEIVED ANY ADDITIONAL INFORMATION INDICATING THAT A PATIENT WAS OR MAY HAVE BEEN HARMED AS A RESULT OF THE REPORTED EVENT. (B)(4) WOULD NOT NORMALLY SUBMIT AN MDR FOR THIS EVENT, BUT IS DOING SO NOW BECAUSE THIS PARTICULAR ISSUE (LEAKY ENFIT CONNECTOR) HAS CAUSED A REPORTABLE INJURY TO A PATIENT WITHIN THE LAST TWO YEARS. THE COMPLAINANT DID NOT RETURN THE AFFECTED SET(S) FOR EVALUATION.

D

Patient 1

THE INITIAL REPORTER STATED THAT THE ADMINISTRATION SET WAS "LEAKING FROM THE WHITE CONNECTOR." THERE WAS NO ADVERSE EVENTS OR DELAY IN THERAPY REPORTED. (B)(4).