MalfunctionMBP
TREL-XPRESS 300 5CC
Received Jan 29, 2014 · Event occurred Jan 9, 2014
Report 2090010-2014-00002 · MDR key 3750784
Device
Generic name
Accell
Catalog number
XPRESS305
Lot number
130947
Product problems
- Device Disinfection Or Sterilization Issue
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED 'THE SCRUB TECH FELT (THE PRODUCT) BOX OPENED TOO EASY (FELT THE) PRODUCT WAS NOT STERILE.' THE PRODUCT WAS NOT USED FOR SURGERY.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.