SPINAL/EPIDURAL NEEDLES & TRAYS
Received Feb 25, 2026 · Event occurred Feb 2, 2026
Report 9610048-2026-00024 · MDR key 24445543
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
408355
Lot number
5112596
Product problems
- Break
- Leak/Splash
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT THE NEEDLE CRACKED, LEAKING MEDICINE AT THE MOMENT OF ADMINISTRATION. ADDITIONAL INFORMATION RECEIVED ON 20-FEB-2026. WAS THERE ANY DAMAGE TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN IN DETAIL. ACCORDING TO THE NURSING REPORT, AS THE MEDICATION LEAKED FROM THE NEEDLE, IT MAY NOT HAVE BEEN ADMINISTERED CORRECTLY. COULD YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? THE NOTIFICATION ARRIVED ON (B)(6) 2026.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: DURING THE ANALYSIS OF THIS COMPLAINT, BATCH HISTORIES, NONCONFORMANCE RECORDS, AND CORRECTIVE MAINTENANCE RECORDS WERE REVIEWED, AND NO RECORDS AND/OR EVIDENCE WERE FOUND THAT COULD LEAD TO THIS COMPLAINT. IN ADDITION, NO PHOTOS WERE PROVIDED FOR ANALYSIS, MAKING IT IMPOSSIBLE TO CONFIRM THE REPORTED DEFECTS. FOR A MORE DETAILED ANALYSIS, THE AVAILABILITY OF THE SAMPLE AND/OR PHOTOS OF THE REPORTED DEFECTS WOULD BE REQUIRED. BASED ON THE INVESTIGATION RESULTS TO DATE, A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS COMPLAINT.
Description of Event or Problem
NO ADDITIONAL INFORMATION.