MalfunctionMEB
INFUSOR
Received Jul 27, 2026 · Event occurred Jun 25, 2026
Report 1416980-2026-02442 · MDR key 50027850
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
25M003
Product problems
- Device Contamination with Chemical or Other Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the tubing of two (2) Small Volume Infusors had black foreign particle. The issue was noticed 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.