FDA.reportPublic FDA data

MAUDE MDR 8293455

MDR report key
8293455
Report number
3009211636-2019-00015
Event key
0
Event type
3
Date of event
2018-12-14
Date received
2019-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA HERNANDEZ
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PALINDROMECATHETER, HEMODIALYSIS, IMPLANTED, COATEDCOVIDIEN MFG SOLUTIONS S.A.NYU8888145044P8888145044P1613900109Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-310

Event Narratives#

N

Patient 1

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION NOTED: THE PHOTOGRAPH DEPICTS THE BLUE AND RED PORTS WITH A SYRINGE ATTACHED TO THE RED PORT. THE YELLOW CAPS ARE ON THE LUMEN. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ACCORDING TO THE REPORTER, DURING TREATMENT, BLOOD LEAK WAS NOTED COMING FROM THE CONNECTION OF THE ARTERIAL (RED) CONNECTOR AND THE EXTENSION TUBE. THEN AFTER A FEW WEEKS, WHILE CHECKING FOR PERMEABILITY OF THE CATHETER, THE VENOUS (BLUE) HAD THE SAME ISSUE. IT WAS STATED THAT THE CONNECTOR WAS CHANGED WITH THE REPAIR KIT, DISTAL CONNECTORS WERE CHANGED AND IV ANTIBIOTICS WAS GIVEN AS AN INTERVENTION. IT WAS STATED THAT CATHETER WAS 1 YEAR OLD. THERE WAS NO REPORTED PATIENT INJURY.