MalfunctionLHI
Baxject II Needless Transfer Device
Received Jul 2, 2026
Report 2032282-2026-00125 · MDR key 25694339
Device
Generic name
Set, I.v. Fluid Transfer
Manufacturer
Takeda Pharmaceuticals U.s.a., Inc.Product problems
- No Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FOLLOW UP INFORMATION REQUESTED FOR FURTHER INVESTIGATION.
Description of Event or Problem
THE DILUTION MECHANISM DID NOT WORK FOR 3 OUT OF 4 VIALS THAT WE HAD TO USE. WHEN PUSHING DOWN ON THE DILUENT VIAL, THE DILUENT DID NOT FLOW INTO THE DRUG. WE HAD TO BREAK THE HOUSING AND MANUALLY RECONSTITUTE THE DRUG."