NI
Received Jul 10, 2026
Report 1416980-2026-02298 · MDR key 25788322
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3/D10: THE EVENTS OCCURRED BETWEEN MACH - APRIL, 2026. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT TWO (2) UNSPECIFIED ELASTOMERIC DEVICES HAD WHITE POWDER EITHER ON THE END OF THE IN THE CREVICES OF THE BLUE CAP/CONNECTOR AND WAS PREDOMINANTLY PRESENT IN THE FILL PORT AT THE POINT OF FINAL RELEASE. THE ISSUE WAS NOTICED PRIOR TO PATIENT USE. THE DEVICES WERE FILLED WITH 5-FLUOROURACIL (5-FU) AND SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.