FDA.reportPublic FDA data

MAUDE MDR 7303982

MDR report key
7303982
Report number
3003504604-2018-00002
Event key
0
Event type
3
Date of event
2018-01-31
Date received
2018-02-28
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#

Address
25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
Phone
224-224-2242
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EFFLUENT BAGSYSTEM, HEMODIALYSIS, REMOTE ACCESSORIESBAXTER HEALTHCARE - BROOKLYN PARKMONNA114423A3152R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-280

Event Narratives#

N

Patient 1

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

THE CUSTOMER OBSERVED A LEAKAGE FROM THE CONNECTION PORT OF A 5L EFFLUENT DRAIN BAG DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.