MalfunctionNNK
CARDINAL HEALTH
Received Apr 20, 2026 · Event occurred Dec 12, 2025
Report 3004824601-2026-00014 · MDR key 24930728
Device
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS ON-GOING, FOLLOWUP IS REQUIRED FOR THIS SUBMISSION.
Description of Event or Problem
ON (B)(6) 2025 CUSTOMER REPORTED THEY ARE FAILING (BOTTOM SPLITS OPEN WHEN PUTTING BIOHAZARD ITEMS IN THEM) AND THEY THEREFORE POSE A RISK OF EXPOSURE. NO ADVERSE EVENTS WERE REPORTED.