3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
Received Jan 19, 2012 · Event occurred Dec 29, 2011
Report 1061932-2012-00181 · MDR key 2421940
Device
Generic name
Calibrator For Cell Indices
Manufacturer
Beckman Coulter, Inc.Model number
ACT 5 CALIBRATORCatalog number
7547175
Lot number
CX436
Product problems
- Leak/Splash
- Loose or Intermittent Connection
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER CALLED ON (B)(6) 2011 REPORTING THAT UPON OPENING A SHIPMENT OF THE ACT 5 CALIBRATOR, ONE OF THE VIAL WAS FOUND TO HAVE LEAKED (APPROXIMATELY 2 ML) INSIDE THE PRODUCT BOX. CUSTOMER STATED THAT THE PACKAGE WAS OPENED TO FIND IF THE VIAL WAS BROKEN BUT FOUND THAT THE VIAL WAS INTACT. CUSTOMER MENTIONED THAT THE REASON FOR THE LEAK WAS THAT THE CAP WAS NOT SCREWED ON TIGHTLY ON ONE OF THE 2 VIALS. THE PACKAGE WAS DISPOSED OF IN CUSTOMER'S BIOHAZARD CONTAINER AND HOTLINE HAD ARRANGED FOR A REPLACEMENT. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF THE EVENT AND NO ONE WAS EXPOSED TO THE LEAK. CUSTOMER ALSO REPORTED THAT NO INJURY HAD RESULTED FROM THE EVENT. ROOT CAUSE FOR THE LEAK IS POTENTIALLY ATTRIBUTED TO THE CAP NOT BEING SCREWED ON TIGHTLY ONTO THE VIAL.
Additional Manufacturer Narrative
METHOD: EVALUATION WAS DONE BY THE CUSTOMER. CUSTOMER STATED THAT THE SEASON FOR THE LEAK WAS THAT THE CAP WAS NOT SCREWED ON TIGHTLY ON ONE OF THE TWO VIALS. (B)(4).