STIMUPLEX® ULTRA 360®
Received Oct 16, 2024
Report 2523676-2024-00936 · MDR key 20462978
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
B. Braun Medical Inc.Catalog number
333642
Product problems
- Sharp Edges
- Sharp Edges
Patient
NA · Unknown
- Nerve Damage
- Nerve Damage
Narrative
Description of Event or Problem
AS REPORTED, BRIEF INQUIRY DESCRIPTION: NERVE DAMAGE FROM NEEDLE SHARPNESS. DETAILED INQUIRY DESCRIPTION: THE BRAUN ONES (NEEDLES) WILL PIERCE THE NERVE SINCE IT'S SHARPER. ANESTHESIA IS HAVING ISSUES AT COPPER RIDGE WITH NERVE INJURIES. 2 SEPARATE EXPERIENCED PROVIDERS AROUND THE SAME TIME HAD PERMANENT POPLITEAL NERVE INJURIES AT OUR SURGERY CENTER USING THE BRAUN NEEDLES.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER: (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.
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.