MalfunctionHQE
MID LABS
Received Aug 28, 2015 · Event occurred Jun 27, 2014
Report 2935428-2015-00001 · MDR key 5045300
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
UNK
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DESPITE THE BENT NEEDLE, PROBE PASSES ALL MID PRODUCTION TESTING AND IS FULLY FUNCTIONAL.
Description of Event or Problem
THE PHYSICIAN WAS USING A OPTIRON SYSTEM. A NEW PACK OF MID LABS VITREOUS CUTTER W/2400CE TUBING WAS OPENED AND FOUND THAT IT WOULD NOT CUT. THE PATIENT HAD NO CONTACT W/THE FAILED PRODUCT. THERE WAS NO PATIENT INJURY. PRODUCT TO BE RETURNED TO MID LABS FOR INVESTIGATION. ASPIRATION TEST: RESULT-PASS, NORMAL FLOW OBSERVED ON TESTER. 60/600 CPM CUT TEST: RESULT-PASS, CLEAN CUTS, CUT LEAK TEST, CLOSE PORT LEAK TEST: RESULT-PASS NO LEAKAGE. RETRACTION TEST: RESULT-PASS.