DESIGN OPTIONS®
Received Jun 1, 2026
Report 2521402-2026-00562 · MDR key 25349843
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
B. Braun Medical Inc.Catalog number
333161
Lot number
0062023051
Product problems
- Break
Patient
32 YR · Female
- Foreign Body In Patient
Narrative
Description of Event or Problem
AS REPORTED VIA MEDSUN (B)(4). DESCRIBE THE EVENT OR PROBLEM: DURING EPIDURAL, CRNA [CERTIFIED REGISTERED NURSE ANESTHETIST] WAS ATTEMPTING TO REMOVE NEEDLE FROM CATHETER, THE CATHETER UNRAVELED.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS A 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.