UMBILICAL CATHETER
Received May 5, 2016
Report 2245270-2016-00028 · MDR key 5634914
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
VYGON (B)(4) HAS DONE A VISUAL EXAMINATION OF THE RETURNED CATHETER. THE FRACTURE SECTION OF THE CATHETER HAS NOT BEEN RETAINED FOR INVESTIGATION. THE CATHETER HAS FRACTURED BETWEEN THE 11 AND 10 CM MARKERS OF THE TUBE. NO OBVIOUS SIGNS OF MATERIAL WEAKNESS HAS BEEN IDENTIFIED. THE FRACTURE SURFACES WERE OBSERVED TO BE ROUGH AND UNEVEN. THESE CHARACTERISTICS COULD BE ASSOCIATED WITH THE OCCURRENCE OF A TENSILE FRACTURE . VYGON(B)(4) DID NOT RECEIVED THIS SAMPLE AND WE HAVE TO CONFIRM THIS FIRST INVESTIGATION. FURTHERMORE , WE HAVE TO VERIFY THAT THE SUTURE HAS NOT CAUSED THIS FRACTURE. WE HAVE NO FURTHER COMPLAINT ON THIS BATCH.
Description of Event or Problem
AFTER INSERTION OF AN UMBILICAL CATHETER , UPON SECURING UMBILICAL ARTERIAL CATHETER WITH SUTURE, AS PER PROTOCOL THE UMBILICAL ARTERIAL CATHETER SUDDENLY DETACHED AT 10,5 CM WITH 10,5 CM OF LINE BEING RETAINED WITHIN THE PATIENT. NO SCALPEL OR SCISSORS WERE BEING USED AT THE TIME THE LINE FRACTURED. THE CONSULTANT ATTEMPTED TO SECURE THE PORTION OF LINE LEFT INSIDE THE PATIENT, BUT WAS UNABLE TO REACH IT. THE BABY REMAINED CLINICALLY AND HAEMODYNAMICALLY STABLE. AN URGENT ABDOMINAL X-RAY CONFIRMED THAT THE SECTION OF THE LINE WAS PRESENT WITHIN THE PATIENT. THE PATIENT REQUIRED SURGICAL REMOVAL OF THE CATHETER BY LAPAROTOMY.