VERIFYNOW P2Y12 TEST DEVICE 85064

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-20 for VERIFYNOW P2Y12 TEST DEVICE 85064 manufactured by Accumetrics.

Event Text Entries

[2825598] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031760-2012-00001
MDR Report Key2640626
Report Source05,06
Date Received2012-06-20
Date of Report2012-06-20
Date of Event2012-04-12
Date Mfgr Received2012-06-11
Device Manufacturer Date2012-04-01
Date Added to Maude2012-08-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street3985 SORRENTO VALLEY BLVD.
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8586431600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERIFYNOW P2Y12 TEST DEVICE
Product CodeJOZ
Date Received2012-06-20
Catalog Number85064
Lot NumberWL0113
Device Expiration Date2013-09-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerACCUMETRICS
Manufacturer Address3985 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-06-20

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