InjuryFOS
UMBILICAL CATHETER
Received Nov 29, 2018 · Event occurred Oct 31, 2018
Report 2245270-2018-00088 · MDR key 8114615
Device
Product problems
- Filtration Problem
- Infusion or Flow Problem
- Filtration Problem
- Infusion or Flow Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
AS NO SAMPLE, NO BATCH NUMBER AND NO FURTHER USER'S INFORMATION ARE AVAILABLE,, NO INVESTIGATION CAN BE DONE. THROMBOSIS IS A POTENTIAL COMPLICATION OF THE USE OF THIS CATHETER. IN THE IFU, WE RECOMMEND TO FLUSH THE CATHETER BEFORE AND AFTER EACH USE WITH SALINE SOLUTION.
Description of Event or Problem
THE CUSTOMER DESCRIBES VENOUS AND THROMBOSIS WITH PROLONGATION OF HOSPITAL STAY AND RISK OF HYPOPERFUSION KIDNEY AND INTESTINE. WE DO NOT KNOWN HOW LONG THE UMBILICAL CATHETER WAS IN PLACE.