UMBILICAL CATHETER
Received Feb 16, 2018 · Event occurred Dec 26, 2017
Report 2245270-2018-00004 · MDR key 7276610
Product problems
- Break
- Material Rupture
- Break
- Material Rupture
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 THESE DEVICES AND ONLY ONE OF THIS BATCH WAS REGISTERED FOR RUPTURE OF THE TUBE DURING INFUSION. THE BATCH REVIEW DO NOT SHOWN ANY DEVIATION OR NON-CONFORMITY. THE TENSILE STRENGTH IS COMPLIANT WITH THE STANDARD ISO 10555-1. THE VALUES ARE GREATER THAN THE SPECIFICATION OF MINI 10N. THE AVERAGE IS 20,1N WITH A MINIMUM AT 16,9N.
Description of Event or Problem
AT THE END OF INSERTING THE UMBILICAL CATHETER, THE HUB BREAK FROM THE CATHETER TUBE. THIS CATHETER WAS REMOVED AND REPLACED BY ANOTHER ONE. NO FURTHER INFORMATION ARE AVAILABLE. FURTHERMORE, NO PATIENT OUTCOME HAS BEEN REPORTED.
Description of Event or Problem
AT THE END OF INSERTING THE UMBILICAL CATHETER, THE HUB BREAK FROM THE CATHETER TUBE. THIS CATHETER WAS REMOVED AND REPLACED BY ANOTHER ONE. NO FURTHER INFORMATION ARE AVAILABLE. FURTHERMORE, NO PATIENT OUTCOME HAS BEEN REPORTED.
Additional Manufacturer Narrative
WE CAN NOTICED THAT THE HUB IS DETACHED FROM THE CATHETER TUBE. THE VISUAL EXAMINATION SHOWS THAT GLUE IS AROUND THE TUBE. THE DIMENSION OF THE TUBE ARE COMPLIANT TO ITS SPECIFICATION. AN ADDITIONAL TEST HAS BEEN DONE ON THE RETAINED SAMPLE , THE TENSILE STRENGTH IS 26,9N FOR A SPECIFICATION OF 10N MINIMUM. THE BATCH REVIEW DOES NOT SHOWN ANY DEVIATION OR NON-CONFORMITY DURING THE ASSEMBLING PROCESS. WE DO NOT REGISTER ANY SIMILAR COMPLAINT ON THIS BATCH. IT IS AN ISOLATED EVENT. THE ROOT CAUSE CANNOT BE DEFINED CLEARLY. A PROBABLE CAUSE OF THIS DISCONNECTION COULD BE A MECHANICAL STRENGTH APPLIED TO THE TUBE/HUB WHICH GLUING WAS PROBABLY UNEVEN. NEVERTHELESS, WE HAVE IMMEDIATELY INFORMED OUR MANUFACTURING STAFF ABOUT THIS DEFECT IN ORDER TO BE VIGILANT DURING THE GLUING PROCESS.