MalfunctionMEB
INFUSOR
Received Jul 2, 2026 · Event occurred Jun 5, 2026
Report 1416980-2026-02226 · MDR key 25700195
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
NI
Product problems
- Material Rupture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BLADDER OF A SMALL VOLUME INFUSOR RUPTURED. THE BLADDER RUPTURE OCCURRED WHILE FILLING THE DEVICE WITH FLUOROURACIL AND SALINE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.