MalfunctionGAA
STERIFIX®
Received Jul 16, 2026
Report 2521402-2026-00691 · MDR key 25843959
Device
Generic name
Needle, Aspiration And Injection, Disposable
Manufacturer
B. Braun Medical Inc.Catalog number
418021
Lot number
0062027660
Product problems
- Contamination /Decontamination Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED BY THE USER FACILITY:YELLOW MATERIAL WAS FOUND INSIDE THE PACKAGE.NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL NUMBER (b)(4).THE INVESTIGATION IS ONGOING AT THIS TIME.A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.