FDA.reportPublic FDA data

MAUDE MDR 3442059

MDR report key
3442059
Report number
1225520-2013-00011
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
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SUSAN FINNERAN
Address
40 GRISSOM RD. STE 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-10-0053R N

Patients#

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

Event Narratives#

D

Patient 1

THE BUTTERFLY CONNECTOR ON THE PREASSEMBLED SYRINGE IN THE GDP WAS CRACKED AND THE BONE GRAFT PREPARATION SQUIRTED OUT WHEN I WAS TRANSFERRING IT BACK TO THE STERILE FIELD. THE SCRUB TECH HAD ALREADY TAKEN IT OFF OF THE SYRINGE THAT IT CAME ON AND HAD PUT IT ON THE 10CC SYRINGE IN THE GDP KIT. WE REMOVED THE CRACKED CONNECTOR AND USED ONE FROM THE SYRINGE KIT. NO IMPACT ON THE CASE OUTCOME OR QUALITY OF THE GRAFT. NO IMPACT ON PT.

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 PORT OF AN INVESTIGATION GDP-10 PRODUCT WAS INSPECTED AND (B)(4) LUER CONNECTORS EXHIBITED A CRACKS. BASED ON THIS INVESTIGATION FIELD ACTION WILL BE INITIATE AND GDP-10 PRODUCT WILL BE RECALLED. THE DISTRICT DIFFICULT WILL BE NOTIFIED.