PERIFIX®
Received Dec 17, 2025
Report 2521402-2025-01588 · MDR key 23833258
Device
Product problems
- Break
- Break
Patient
72 YR · Female
- Foreign Body In Patient
- 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 BY MEDSUN NUMBER (B)(4): DESCRIBE THE EVENT OR PROBLEM: ABLE TO GET TO INTRATHECAL SPACE WITH CSF (CEREBRAL-SPINAL FLUID) COMING BACK IN TOUHY NEEDLE ON FIRST ATTEMPT. CATHETER THREADED WITH NO RESISTANCE. ON WITHDRAWAL OF TOUHY NEEDLE, CATHETER TEARED AT 21 CM MARK. WENT TO REMOVE IT AND CATHETER PIECE HAD MIGRATED INTO THE THECAL SAC SO CASE WAS ABORTED. CATHETER PIECE REMAINS IN PATIENT BODY.