DESIGN OPTIONS®
Received Jun 18, 2026
Report 2521402-2026-00626 · MDR key 25545396
Device
Product problems
- Break
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE AND/OR LOT NUMBER WERE PROVIDED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A SAMPLE AND/OR LOT NUMBER. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: FX CATHETER WAS THREADED INTO THE LUMBAR AREA. WHEN THE CLINICIAN WENT TO PULL THE CATHETER AFTER THE CASE, 4-5 CM OF FRACTURED CATHETER REMAINED INSIDE THE PATIENT.