DIRECTCHECK ACT+ ABNORMAL
Received Nov 2, 2017 · Event occurred Oct 24, 2017
Report 2250033-2017-00006 · MDR key 6996101
Device
Generic name
Plasma, Coagulation Control
Manufacturer
Accriva DiagnosticsModel number
DCJACT-ACatalog number
DCJACT-A
Lot number
C7DCA008
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
55 YR
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
(B)(4). SINCE THIS COMPLAINT IS NOT RELATED TO PRODUCT PERFORMANCE AND THE DEVICE WILL NOT BE EVALUATED, THIS SUBMISSION IS CONSIDERED A FINAL REPORT.
Description of Event or Problem
HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY DURING RECONSTITUTION OF A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPED VIAL CONTAINING DILUENT. THE END-USER WAS NOT WEARING GLOVES AND DID NOT USE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT. THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD END USERS AGAINST POTENTIAL INJURY DURING RECONSTITUTION OF THE CONTROL. WHEN CRUSHING THE VIAL, A GLASS SHARD PROTRUDED THROUGH THE DROPPER VIAL AND PUNCTURED THE USER'S RIGHT THUMB. THE END USER IMMEDIATELY WASHED THE AREA WITH SOAP AND WATER AND COVERED THE CUT WITH A BAND AID. NO FURTHER MEDICAL ATTENTION WAS SOUGHT. NO SIGNIFICANT BLOOD LOSS OR MEDICAL COMPLICATIONS WERE REPORTED.