MalfunctionFPB
MEDEX
Received Jul 25, 2022 · Event occurred Jul 5, 2022
Report 15093603 · MDR key 15093603
Device
Product problems
- Fluid/Blood Leak
- Product Quality Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AT 12:30 LIPID FILTER NOTED TO HAVE A SMALL DROP OF LIPIDS LEAKING FROM CONNECTION SITE. LIPIDS WERE THEN CLAMPED AND TURNED OFF PROVIDERS WERE MADE AWARE. MANUFACTURER RESPONSE FOR IV TUBING, MEDEX, NON-DEHP EXT SET 1.2-MICRON FILTER (PER SITE REPORTER). EMAILED REPRESENTATIVE EXPLAINING THE ISSUE AND REQUESTED AN RMA. SIMILAR PROBLEMS IN MAUDE. (B)(6) IDENTIFIED COMPLAINT CASE #(B)(4); SHIPPING LABEL RECEIVED; DEFECT SAMPLE TO BE SHIPPED UPS TODAY.