UMBILICAL CATHETER
Received Jan 23, 2018 · Event occurred Jan 12, 2018
Report 2245270-2018-00003 · MDR key 7213183
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE MALFUNCTIONING DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. WE HAVE CHECKED THE HISTORY OF COMPLAINTS ON THIS DEVICES AND NO FURTHER COMPLAINT ARE REGISTERED ON THIS BATCH.
Description of Event or Problem
A LEAKAGE AT THE END OF THE UMBILICAL CATHETER WAS NOTICED DURING THE CHANGE OF THE INFUSION LINE. THIS CATHETER WAS REMOVED . NO FURTHER INFORMATION ARE AVAILABLE. WE DO NOT KNOWN HOW LONG THIS UMBILICAL WAS IN PLACE. FURTHERMORE, NO PATIENT OUTCOME IS REPORTED.
Additional Manufacturer Narrative
WE CAN NOTICE THAT A GREEN CLAMP HAS BEEN ADDED ON THE TUBE. SEE PICTURE: THERE IS NO CLAMP WITH THE UMBILICAL CATHETER. THE EXAMINATION OF THE SAMPLE SHOWS THAT : A LEAKAGE AT THE CATHETER TUBE NEAR TO THE HUB. IT HAS BEEN CUT BY A REPETITIVE USE OF THE CLAMP. THE DISTAL CATHETER'S TIP HAS BEEN CUT BY THE USER. THIS IS NOT RECOMMENDED. THE BATCH REVIEW DOES NOT SHOWN ANY DEVIATION OR NON CONFORMITY DURING THE MANUFACTURING PROCESS. FURTHERMORE, A 100% KEAKAGE TEST IS PERFORMED DURING THE PROCESS. THIS EVENT IS CLEARLY NOT LINKED TO THE UMBILICAL CATHETER. IT IS A USER MISUSE; NO CLAMP SHOULD BE USED ON SUCH CATHETER AND THE ROUNDED DISTAL TIP SHOULD NOT BEEN CUT. NEVERTHELESS, IT IS AN ISOLATED EVENT.
Description of Event or Problem
A LEAKAGE AT THE END OF THE UMBILICAL CATHETER WAS NOTICED DURING THE CHANGE OF THE INFUSION LINE. THIS CATHETER WAS REMOVED . NO FURTHER INFORMATION ARE AVAILABLE. WE DO NOT KNOWN HOW LONG THIS UMBILICAL WAS IN PLACE. FURTHERMORE, NO PATIENT OUTCOME IS REPORTED.