INSYTE AUTOGUARD
Received May 18, 2026 · Event occurred May 4, 2026
Report 9610048-2026-00072 · MDR key 25209103
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
408380
Lot number
5167400
Product problems
- Inaccurate Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE LABEL CONTENT IS INCORRECT. IT WAS REPORTED THAT THE ITEM SKU MAFRA 000310 - RAQUI SPINAL ANESTHESIA NEEDLE 26G X 3 1/2 CX 25UN BD 408380 - EAN 37891463005657 WAS LABELED WITH THE EAN BELONGING TO ANOTHER PRODUCT, SKU MAFRA 008817 - PERI TUOHY ANESTHESIA NEEDLE 18G X 3 1/2 CX 25UN BD 408359 - EAN 37891463005565. THIS IS A DIVERGENCE OF EANS IN THE PHYSICAL IDENTIFICATION, SINCE EACH EAN CORRESPONDS TO A DIFFERENT SKU.
Additional Manufacturer Narrative
B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
Additional Manufacturer Narrative
CORRECTION @ COMMON DEVICE NAME.
Description of Event or Problem
NO ADDITIONAL INFORMATION.