EASYPUMP
Received Jun 29, 2026
Report 9610825-2026-00335 · MDR key 25650243
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
B Braun Melsungen AgCatalog number
4540008-07
Lot number
25M29GED41
Product problems
- Excess Flow or Over-Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. 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.
Description of Event or Problem
ACCORDING TO THE EVENT DESCRIPTION: EASYPUMP II ELASTOMERIC PUMPS FINISHING EARLIER THAN EXPECTED AT (B)(6).