UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
Received Jan 2, 2015 · Event occurred Nov 28, 2014
Report 3007966929-2014-00138 · MDR key 4381452
Device
Product problems
- Disconnection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE HEALTH CARE PROFESSIONAL REPORTED THE UNOMETER SAFETI PLUS WAS ATTACHED TO THE PATIENT'S CATHETER ON (B)(6) 2014 AND REPEATEDLY DISCONNECTED FROM THE CATHETER STARTING AROUND 09:00 PM THAT EVENING. THE HEALTH CARE PROFESSIONAL REPORTED WHEN RECONNECTING THE UNOMETER SAFETI PLUS TO THE CATHETER THE NURSES ENSURED THAT THERE WAS A FIRM CONNECTION. THE UNOMETER SAFETI PLUS WAS DISCONTINUED FROM THE PATIENT AROUND 12:00 PM ON (B)(6) 2014, AFTER APPROXIMATELY NINE (9) HOURS OF USE.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. THE FACILITY WAS UNABLE TO DETERMINE THE LOT NUMBER FOR THE DEVICE INVOLVED BUT, INDICATED THE DEVICE MAY HAVE BEEN FROM LOT 162157 OR 161560. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.