ACT VIALED WHOLE BLOOD CONTROL
Received Mar 8, 2018 · Event occurred Feb 28, 2018
Report 2250033-2018-00005 · MDR key 7325813
Device
Generic name
Plasma, Coagulation Control
Manufacturer
Accriva DiagnosticsModel number
QCACTCatalog number
QCACT
Product problems
- Device Handling Problem
- Device Handling Problem
Patient
Not reported
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
(B)(4). THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS NOT VALID. THEREFORE, THE DATE OF MANUFACTURE, LOT NUMBER AND EXPIRY DATE ARE UNKNOWN. PROCESS EVALUATION COULD NOT BE PERFORMED.
Description of Event or Problem
OCCUPATIONAL HEALTH NURSE REPORTED A NEEDLE STICK INJURY SUSTAINED BY AN END USER PERFORMING QC TESTING WITH A HEMOCHRON 801 ACT TUBE COAGULATION SYSTEM. WHILE WITHDRAWING THE QC MATERIAL FROM THE QCACT VIAL, THE NEEDLE SLIPPED AND PUNCTURED THE END USER'S MIDDLE FINGER ON HER LEFT HAND. THE END USER SQUEEZED THE INVOLVED BODY PART AND WASHED IT WITH SOAP AND WATER THREE TIMES. THE END USER ALSO APPLIED PROVIDONE IODINE. NO ADDITIONAL MANAGEMENT WAS ADMINISTERED BY THE OCCUPATIONAL HEALTH NURSE.
Additional Manufacturer Narrative
LOT NUMBER E7TCA004.
Description of Event or Problem
FOLLOW-UP #1.