UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Feb 6, 2016 · Event occurred Dec 18, 2015
Report 3007966929-2016-00001 · MDR key 5414652
Device
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(6) 2019. (B)(6) 2014. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE DEVICE WAS NOT USED ON A PATIENT. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A DETAILED BATCH REVIEW FOR THIS LOT NUMBER WAS PERFORMED, IT WAS CONCLUDED THAT THERE WAS NO DISCREPANCY RELATED TO THIS COMPLAINT ISSUE. A PREVIOUS INVESTIGATION REVEALED AN UNIDENTIFIABLE ROOT CAUSE AND REQUIRED NO CORRECTIVE ACTIONS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITHOUT FURTHER ACTION. (B)(4).
Description of Event or Problem
IT WAS REPORTED FROM A PHARMACIST THAT THE MEASURING CHAMBER WAS BROKEN ON THE UNOMETER, THE PRODUCT WAS UNUSED.