FDA.reportPublic FDA data

MAUDE MDR 3440404

MDR report key
3440404
Report number
1225520-2013-00013
Event key
0
Event type
3
Date of event
2013-08-27
Date received
2013-09-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SUSAN FINNERAN
Address
40 GRISSOM RD. SUITE 100 PLYMOUTH MA 02360 US
Phone
508-508-5087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HARVEST GRAFT DELIVERY SYSTEMPISTON SYRINGEHARVEST TECHNOLOGIES CORPORATIONFMFGDP-10GDP-10GDP-10-0051R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-090

Event Narratives#

D

Patient 1

SITE REPORTED THAT GDP-10 HARVEST GRAFT DELIVERY SYSTEM WAS INSPECTED UPON OPENING AND THAT THE LUER CONNECTOR WAS CRACKED. WE OPENED THE GDP AND INSPECTED THE BUTTERFLIES. WE FOUND A CRACK IN TWO OF THEM SO WE DID NOT USE THEM. THERE WAS NO IMPACT, INJURY OR DELAYS. WE DID NOT USE THESE BUTTERFLY'S AND WERE ABLE TO USE THE OTHER CONNECTORS IN THE GDP KIT.

N

Patient 1

IN TOTAL HARVEST RECEIVED 13 REPORTS OF GDP-10 LEAKS AT THE LUER CONNECTOR. EACH REPORT HAS BEEN SUBMITTED TO FDA AS A SEPARATE MDR. AS PART OF AN INVESTIGATION GDP-10 PRODUCT WAS INSPECTED AND 2/135 LUER CONNECTORS EXHIBITED A CRACKS. BASED ON THIS INVESTIGATION FIELD ACTION WILL BE INITIATE AND GDP-10 PRODUCT WILL BE RECALLED. THE DISTRICT OFFICE WILL BE NOTIFIED.