DXH CELL LYSE
Received Feb 21, 2012 · Event occurred Jan 27, 2012
Report 1061932-2012-00562 · MDR key 2463132
Device
Generic name
Products, Red-cell Lysing Products
Manufacturer
Beckman Coulter, Inc.Catalog number
628019
Lot number
1710002
Product problems
- Leak/Splash
- Device Slipped
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
UPON FURTHER REVIEW, BECKMAN COULTER, INC. (BEC) HAS DETERMINED THAT THE MALFUNCTIONED DEVICE WOULD NOT LIKELY CAUSE DEATH OR SERIOUS INJURY UPON RECUR. BEC HAS DETERMINED THAT THE INCIDENT REPORTED BY THE CUSTOMER WAS NOT AN MDR REPORTABLE EVENT.
Description of Event or Problem
CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT SHE RECEIVED A BOX OF DXH CELL LYSE 5L THAT WAS LEAKING. CUSTOMER REPORTED THAT THE BOX WAS WET AND OTHER BOXES IN THE SHIPMENT WERE ALSO WET. CUSTOMER REPORTED THAT THE CAP ON THE DXH CELL LYSE 5L BOTTLE WAS NOT ATTACHED SECURELY TO THE BOTTLE. CUSTOMER REPORTED THAT SHE HAD A SMALL CUT ON HER HAND WHICH WAS COVERED BY A BAND AID. CUSTOMER REPORTED THAT SHE DID NOT GET THE FLUID ON HER WOUND. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.
Additional Manufacturer Narrative
(B)(4).