MalfunctionMEB
INFUSOR
Received Jun 19, 2026 · Event occurred May 20, 2026
Report 1416980-2026-02109 · MDR key 25567960
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
25K026
Product problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE BLADDER OF A SMALL VOLUME INFUSOR RUPTURED. THIS OCCURRED IN THE PHARMACY DEPARTMENT DURING MANUAL FILLING OF THE DEVICE USING A SYRINGE. THE DEVICE WAS BEING FILLED WITH FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.