FDA.reportPublic FDA data

MAUDE MDR 2640626

MDR report key
2640626
Report number
2031760-2012-00001
Event key
0
Event type
3
Date of event
2012-04-12
Date received
2012-06-20
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#

Address
3985 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US
Phone
858-858-8586
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERIFYNOW P2Y12 TEST DEVICEACCUMETRICSJOZ85064WL0113R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-2001. R

Event Narratives#

D

Patient 1

FINGER STICK TO AN EXPOSED VERIFYNOW TEST DEVICE NEEDLE. AFTER TESTING THE TECH INITIALLY THREW OUT THE INTACT VACUTAINER/TEST DEVICE INTO THE MEDICAL WASTE CONTAINER PER THE PACKAGE INSERT INSTRUCTIONS. LATER IN AN ATTEMPT TO RESOLVE A TEST DISCREPANCY, TECH RETRIEVED THE INTACT TEST DEVICE / VACUTAINER FROM THE MEDICAL WEST CONTAINER AND REMOVED THE VACUTAINER FROM THE TEST DEVICE. AFTER THE TECH REMOVED THE VACUTAINER FROM THE TEST DEVICE AND RESOLVED THE DISCREPANCY, THE TECH WENT TO THROW OUT THE SEPARATED TEST DEVICE AND VACUTAINER AND INADVERTENTLY INSERTED A FINGER INTO THE SAMPLE WELL OF THE TEST DEVICE WHERE THE NEEDLE IS HOUSED. DEVICE NEEDLE EXPOSURE (FINGER STICK) OCCURRED AFTER TECH REMOVED SAMPLE VACUTAINER VIAL FROM DEVICE SAMPLE WELL. WOUND WAS TREATED BY THOROUGH CLEANING.