Umbilical Catheter
Received Jul 31, 2026 · Event occurred Jul 9, 2026
Report 2245270-2026-00099 · MDR key 50097883
Product problems
- Fluid/Blood Leak
- Positioning Problem
Patient
Unknown
- Low Blood Pressure/ Hypotension
- Elevated ketones/Diabetic Ketoacidosis
- Ascites
Narrative
Description of Event or Problem
Patient hypotensive and requiring extensive inotropic support, worsening metabolic acidosis and overall stability. Chest/abdo xray showed gasless abdomen vs ascites. UVC low-lying. On ultrasound, ascites found and concern for UVC going interstitial prompted team to do paracentesis, place PIV, remove UVC and place a PICC on day 1 of life. Approximately 43 mL of TPN-like fluid aspirated from abdomen, patient stabilized after same.
Additional Manufacturer Narrative
Once the sample is received an investigation will be completed per procedure. The results of the investigation will be forwarded to the FDA via a follow up MDR.