PERIFIX®
Received Jan 13, 2025 · Event occurred Nov 28, 2024
Report 2523676-2024-01165 · MDR key 21137177
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
B. Braun Medical Inc.Product problems
- Break
- Break
Patient
19 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 REPORTED PER MEDWATCH MW5163347: DESCRIBE EVENT OR PROBLEM: BROKEN AND RETAINED EPIDURAL CATHETER TIP. CATHETER REMOVED WITHOUT RESISTANCE AND ON INSPECTION, APPROXIMATELY 1-2 CM OF CATHETER WAS RETAINED IN THE PATIENT.