NAMIC
Received Aug 4, 2025 · Event occurred Jul 23, 2025
Report 22698172 · MDR key 22698172
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Medline Industries, Inc.Model number
70015003Catalog number
70015003
Lot number
0000109868
Product problems
- Crack
- Fluid/Blood Leak
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
STOPCOCK DEVICE FOUND TO BE LEAKING WITH IMPORTANT FLUIDS RUNNING THROUGH LINE. WE HAVE HAD 3 OCCURRENCES IN THE PAST WEEK THAT WE IDENTIFIED THERE WAS A HOLE AT THE STOPCOCK, AND THE OTHERS WERE FOUND TO BE CRACKED. WE HAVE REACHED OUT TO THE SUPPLIER MEDLINE AND THEY HAVE TAKEN THE PRODUCTS AND ARE LAUNCHING AN INVESTIGATION. WE NOW HAVE A SUBSTITUTE PRODUCT AVAILABLE. WILL WORK WITH NICU [NEONATAL INTENSIVE CARE UNIT] TEAM, MEDLINE AND CSS [CLINICAL STABILIZATION SERVICES] TO FIGURE OUT NEXT STEPS. PRODUCT INFORMATION: NAMIC STOPCOCK, REF-70015003, LOT-0000109868.