MalfunctionEXR
UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Jun 30, 2015 · Event occurred Jun 17, 2015
Report 3007966929-2015-00058 · MDR key 4890933
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE NURSE REPORTS WHEN REMOVING THE UNOMETER SAFETI PLUS DRAINAGE BAG FROM THE PATIENT'S BED THE TUBING THAT CONNECTS THE URINARY CATHETER TO THE 'TOP OF THE DRAINAGE BAG' WAS 'COMPLETELY DETACHED'.