MalfunctionKJG
SPIKE ADAPTER
Received Aug 8, 2025 · Event occurred Jul 18, 2025
Report MW5174282 · MDR key 22755214
Device
Generic name
Tube, Tissue Culture
Manufacturer
Origen Biomedical, Inc.Model number
REF 2S-P20Lot number
V23141
Product problems
- Disconnection
Patient
41 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHEN PATIENT WAS RECEIVING STEM CELLS, RN ATTEMPTED TO PULL OUT SPIKE FROM FIRST BAG OF CELLS TO SPIKE THE SECOND BAG OF CELLS, AND THE SPIKE DISCONNECTED FROM THE TUBING. NEW SPIKE ACQUIRED AND CONNECTED TO TUBING. NO CELLS WERE LOST AND PATIENT WAS NOT HARMED.