DIRECTCHECK CITRATE PT ABNORMAL
Received May 3, 2017 · Event occurred May 1, 2017
Report 3002721930-2017-00009 · MDR key 6541341
Device
Generic name
Plasma, Coagulation Control
Manufacturer
Accriva DiagnosticsModel number
DCJCPT-ACatalog number
DCJCPT-A
Lot number
M6DAC011
Product problems
- Improper or Incorrect Procedure or Method
- Adverse Event Without Identified Device or Use Problem
- Improper or Incorrect Procedure or Method
- Adverse Event Without Identified Device or Use Problem
Patient
30 YR
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
THIS MDR SUBMITTED ON 05/03/2017 REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4). (B)(4).
Description of Event or Problem
HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY WHILE DISPENSING A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. WHEN RECONSTITUTING THE CONTROL, THE END-USER WORE GLOVES BUT FAILED TO UTILIZE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT. THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD THE END USER AGAINST POTENTIAL INJURY WHILE HANDLING THE CONTROL. THE END USER SQUEEZED THE VIAL AND SUSTAINED A SMALL CUT TO HER RIGHT THUMB PAD WHICH WAS CAUSED BY A PIECE OF GLASS PIERCING THE WALL OF THE VIAL. THE END USER WASHED THE AFFECTED AREA WITH SOAP AND WATER AND APPLIED A BAND AID. NO FURTHER MEDICAL ATTENTION WAS SOUGHT AND NO COMPLICATIONS WERE DOCUMENTED.