SYNCHRON CX ALBUMIN REAGENT
Received Nov 15, 2011 · Event occurred Sep 14, 2010
Report 2050012-2011-07407 · MDR key 2393311
Device
Product problems
- Leak/Splash
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT FIVE UNITS OF SYNCHRON CX ALBUMIN REAGENT LEAKED UPON RECEIPT. NO INJURIES WERE REPORTED.
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR EVAL, ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS IS ONE OF FIVE MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED FIVE INDIVIDUAL UNITS WERE INVOLVED. REFERENCE THE BELOW MDR NUMBERS FOR ALL ASSOCIATED REPORTS: 2050012-2010-00946, 2050012-2011-07406, 2050012-2011-07408, 2050012-2011-07409. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 FOR ADD'L REPORTABLE EVENTS.
Remedial action
- Modification/Adjustment
- Notification