FDA.reportPublic FDA data

MAUDE MDR 9908042

MDR report key
9908042
Report number
1416980-2020-01879
Event key
0
Event type
3
Date of event
2020-03-05
Date received
2020-03-31
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
1CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SETSET, ADMINISTRATION, INTRAVASCULARBAXTER HEALTHCARE CORPORATIONFPANAUC8519DR20A20051R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE SEVERED. THE CUT IN THE SET WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.