UMBILICAL CATHETER
Received Feb 24, 2021 · Event occurred Jan 18, 2021
Report 2245270-2021-00016 · MDR key 11371916
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- Extravasation
- Angioedema
- Extravasation
- Angioedema
Narrative
Additional Manufacturer Narrative
THE SAMPLE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THE VISUAL EXAMINATION SHOWS THAT THE CATHETER IS CONFORM, NO ANOMALY COULD BE NOTICED. THE CATHETER HAS BEEN TESTED, THERE IS NO OBSTRUCTION. THE TIGHTNESS WAS CHECKED UNDER AIR PRESSURE, THERE IS NO LEAKAGE. THE DISTAL TIP OF THE CATHETER IS ROUNDING AS EXPECTED. FURTHERMORE, THESE UMBILICAL CATHETERS ARE 100% CHECKED DURING THE MANUFACTURING PROCESS. THIS EVENT IS NOT LINKED TO A DEFECT OF THE CATHETER. THE USER HAS NO FURTHER INFORMATION CONCERNING THE REGULAR CHECK OF THE POSITION OF THIS CATHETER AND ITS INSERTION DATE. EXTRAVASATION IS A WELL-KNOWN COMPLICATION OF CATHETERS. THE BATCH REVIEW DOES NOT SHOW ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICE IS COMPLIANT TO NORM ISO 10555-1.THE TIGHTNESS AND THE ROUNDED TIP OF EACH UMBILICAL CATHETER ARE CONTROLLED. THERE IS NO OTHER COMPLAINT ON THIS BATCH AND NO SIMILAR COMPLAINT ON THIS PRODUCT REFERENCE.
Description of Event or Problem
EXTRAVASATION OF TPN FLUID IN THE SURROUNDING TISSUES THROUGH THE UMBILICAL CATHETER.AN OEDEMA IS LOCATED AND THE INFUSION STOPPED.THE UMBILICAL CATHETER HAS BEEN REMOVED AND REPLACED BY A PERIPHERAL VENOUS CATHETER .
Additional Manufacturer Narrative
THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION. THE BATCH REVIEW DOES NOT SHOWN ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICE IS COMPLIANT TO NORM ISO (B)(4). THE TIGHTNESS AND THE ROUNDED TIP OF EACH UMBILICAL CATHETER ARE CONTROLLED . THERE IS NO OTHER COMPLAINT ON THIS BATCH AND NO SIMILAR COMPLAINT ON THIS PRODUCT REFERENCE. EXTRAVASATION COULD BE A COMPLICATION DUE TO A VESSEL PERFORATION OR A WEAKNESS OF THE VESSEL WALL.
Description of Event or Problem
EXTRAVASATION OF TPN FLUID IN THE SURROUNDING TISSUES THROUGH THE UMBILICAL CATHETER. AN OEDEMA IS LOCATED AND THE INFUSION STOPPED. THE UMBILICAL CATHETER HAS BEEN REMOVED AND REPLACED BY A PERIPHERAL VENOUS CATHETER. NO FURTHER INFORMATION RELATED TO THE PLACEMENT CONTROL, THE USE DURATION AND TO THE PATIENT ARE AVAILABLE.