EASYPUMP
Received Jun 17, 2026 · Event occurred May 20, 2026
Report 9610825-2026-00316 · MDR key 25534779
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
B.braun Melsungen AgCatalog number
4540016-07
Lot number
25K20GED81
Product problems
- Crack
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: DURING THE 5-FU FILLING STEP, THE FILLING PORT CRACKED AND CAUSED 5-FU LEAKS. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K081905.