FDA.reportPublic FDA data

MAUDE MDR 3442082

MDR report key
3442082
Report number
1225520-2013-00012
Event key
0
Event type
3
Date of event
2013-08-19
Date received
2013-09-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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, CORP.FMFGDP-10GDP-10GDP-10-0054R N

Patients#

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

Event Narratives#

D

Patient 1

SITE REPORTED THAT GDP-10 HARVEST GRAFT DELIVERY SYSTEM FAILED AT THE LUER CONNECTOR. THE LUER CONNECTOR WAS DISCONNECTED. THERE WAS NO REPORT OF PT OR USER INJURY. THIS WAS FOUND AS I WENT TO DELIVER THE BONE GRAFT PREPARATION TO THE FIELD. TECH WAS DRAWING SLOWLY AND WE DISCOVERED IT WAS DEFECTIVE IMMEDIATELY. NO BONE GRAFT PREPARATION SQUIRTED OUT. TECH IMMEDIATELY TOOK IT OFF AND HANDED IT TO ME. ABSOLUTELY NO IMPACT ON PT, PT WAS NOWHERE NEAR WHERE WE WERE WORKING AND WAS COVERED BY DRAPES, NO DELAY IN PROCEDURE, NO IMPACT ON DOCTOR.

N

Patient 1

IN TOTAL HARVEST RECEIVED (B)(4) REPORTS OF GDP-10 LEAKS AT THE LUER CONNECTOR. EACH REPORT HAS BEEN SUBMITTED TO FDA AS A SEPARATE MDR. AS PORT OF AN INVESTIGATION GDP-10 PRODUCT WAS INSPECTED AND 2/135 LUER CONNECTORS EXHIBITED A CRACKS. BASED ON THIS INVESTIGATION FIELD ACTION WILL BE INITIATED AND GDP-10 PRODUCT WILL BE RECALLED. THE DISTRICT OFFICE WILL BE NOTIFIED.