UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Feb 11, 2015 · Event occurred Jan 27, 2015
Report 3007966929-2015-00025 · MDR key 4511145
Device
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE INTENSIVE CARE UNIT (ICU) NURSE REPORTS THE BURETTE SEPARATED FROM THE MAIN COLLECTION CHAMBER OF THE UNOMETER SAFETI PLUS WHILE THE PATIENT WAS BEING ESCORTED FROM THE BATHROOM AND 'URINE SPILLED OVER THE FLOOR AND SPLASHED ONTO THE ICU NURSE WHO WAS ESCORTING THE PATIENT.' THE ICU NURSE FURTHER REPORTS THE UNOMETER SAFETI PLUS WAS IN PLACE FOR TWO DAYS WHEN THE BURETTE SEPARATED FROM THE MAIN COLLECTION CHAMBER. IT WAS ALSO REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS REPLACED.
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. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.