UMBILICAL CATHETER
Received Jun 19, 2025 · Event occurred Jun 8, 2025
Report 2245270-2025-00057 · MDR key 22293770
Product problems
- Malposition of Device
- Positioning Problem
- Malposition of Device
- Positioning Problem
Patient
NA · Unknown
- Extravasation
- Foreign Body In Patient
- Extravasation
- Foreign Body In Patient
Narrative
Description of Event or Problem
AN UMBILICAL CATHETER WAS INSERTED AT DAY 0 ON A PREMATURE NEWBORN OF 28 WEEKS. 2 DAYS LATER AN EXTRAVASATION OF PARENTERAL WAS NOTICED. THE CATHETER WAS LOCATED IN THE LIVER. THE PREMATURE DIED ON (B)(6) 2025.
Additional Manufacturer Narrative
THE INVOLVED UMBILICAL CATHETER IS NOT AVAILABLE. FROM THE DESCRIPTION, THIS SERIOUS ADVERSE EVENT IS CLEARLY RELATED TO THE MALPOSITION OF THE UMBILICAL CATHETER IN THE LIVER. IT IS NOT TRACED TO A DEFECT OF OUR DEVICE. THE BATCH REVIEW DOES NOT SHOW ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. ALL CONTROLS ARE COMPLIANT, INCLUDING THE 100% TESTS CARRIED OUT ON EACH CATHETER DURING THE MANUFACTURING PROCESS. THESE TESTS ARE AS FOLLOWS: THE BLUNTNESS OF THE CATHETER TIP, MARKING THE CATHETERS, TIGHTNESS AND NON-OBSTRUCTION. THIS SERIOUS ADVERSE EVENT IS NOT TRACED TO A MALFUNCTION OR DEFECT OF OUR DEVICE.