MalfunctionFPK
ICU MEDICAL
Received Dec 11, 2025 · Event occurred Sep 24, 2025
Report 23778243 · MDR key 23778243
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Icu Medical, Inc.Model number
B9768Catalog number
B9768
Lot number
14146755
Product problems
- Break
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE USING ICU MEDICAL REF: B9768 MAIN IV TUBING WITH MEDLINE SECONDARY TUBING REF: DYNDTB1540, THE UNIT HAS HAD A DOZEN SECONDARY TUBING TIPS BREAK IN THE PROXIMAL PORT OF THE MAIN IV TUBING. THIS HAS NEVER HAPPENED UNTIL TWO WEEKS AGO. THIS PROBLEM HAS OCCURRED WITH MULTIPLE PRACTITIONERS. IT CREATES A SIGNIFICANT PROBLEM WHEN THE SECONDARY TUBING IS DISCONNECTED, AS IT CANNOT BE RECONNECTED, AND SALINE FROM THE LITER BAG RAPIDLY LEAKS OUT.