SPINAL/EPIDURAL NEEDLES & TRAYS
Received Jun 4, 2026 · Event occurred Jan 14, 2026
Report 9610048-2026-00077 · MDR key 25393405
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
408380
Lot number
5293507
Product problems
- Inaccurate Information
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
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 ITEM SKU MAFRA 000310 - RAQUI SPINAL ANESTHESIA NEEDLE 26G X 3 1/2 CX 25UN, WAS LABELED WITH THE INCORRECT LABEL INFORMATION. THIS IS A DIVERGENCE OF EANS IN THE PHYSICAL IDENTIFICATION, SINCE EACH EAN CORRESPONDS TO A DIFFERENT SKU. HAS THERE BEEN ANY DAMAGE TO PATIENT'S HEALTH? IF YES, PLEASE EXPLAIN IN DETAIL. NO COULD YOU CONFIRM THE DATE (DD/MM/YYYY) ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? (B)(6) 2026.