InjuryFPB
PALL IV FILTER 0.2 MM
Received Sep 23, 2022 · Event occurred Sep 13, 2022
Report MW5112259 · MDR key 15485289
Device
Product problems
- Disconnection
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FILTER BROKE LOOSE FROM THE CONNECTION TO THE IV TUBING SET AFTER BEING APPROPRIATELY CONNECTED AND LEAKED ONTO THE FLOOR. CHEMOTHERAPY SPILL HAD TO BE CLEANED BY NURSING STAFF. FDA SAFETY REPORT ID # (B)(4).