BALANCED SALT SOLUTION
Received Feb 28, 2011
Report 9614546-2011-00006 · MDR key 2002836
Device
Generic name
Bss
Manufacturer
Abbott Medical OpticsModel number
ENDOSOLCatalog number
ENDOSOL
Lot number
10E0308
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Concussion
Narrative
Additional Manufacturer Narrative
WITHOUT HAVING THE SAMPLE OF THE POTENTIAL DEFECTIVE LABEL IT IS NOT POSSIBLE TO PERFORM AN INVESTIGATION APART FROM THE FORMAL BATCH REVIEW AND RETAIN SAMPLES VERIFICATION. THE REVIEW OF THE BATCH RECORD DID NOT REVEAL ANY DEVIATION OR NON-CONFORMITY RELATED TO THIS COMPLAINT FROM ALL THE CHECKS CARRIED OUT ON THE PRODUCT DURING MANUFACTURING PROCESS. NO ISSUES WERE FOUND ALSO FROM THE REVIEW OF THE RETAINED SAMPLES OF THE INVOLVED BATCH 10E0308. NO OTHER COMPLAINTS WERE RECEIVED FOR BATCH 10E0308 AND NO SIMILAR REPORTS WERE RECEIVED FOR THIS PRODUCT. WE ARE NOT ABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THIS EVENT. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.
Description of Event or Problem
ACCOUNT REPORTED THE BOTTLE FELL FROM THE I.V. POLE WHEN THE SUPPORTING STRAP BROKE AS THE PHACO MACHINE WITH I.V. POLE WAS BEING MOVED BY A MEMBER OF THE O.R. STAFF. BOTTLE STRUCK THE STAFF MEMBER ON THE HEAD CAUSING A MILD CONCUSSION.