UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Feb 6, 2016 · Event occurred Dec 19, 2015
Report 3007966929-2016-00002 · MDR key 5414665
Device
Product problems
- Device Damaged Prior to Use
- Device Damaged Prior to Use
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
REPORT FROM A PHARMACIST STATING THAT "THE CATHETER CONNECTOR IS BROKEN WHERE THE UNOMETER DEVICE IS CONNECTED TO THE FOLEY CATHETER" REPORTER STATED THAT THE PRODUCT WAS NOT USED.