SPINAL/EPIDURAL NEEDLES & TRAYS
Received Feb 9, 2026 · Event occurred Jan 24, 2026
Report 9610048-2026-00020 · MDR key 24290695
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
NS408359
Lot number
5204879
Product problems
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION: UPON FURTHER REVIEW OF THIS COMPLAINT, IT WAS DETERMINED THAT THE AWARE DATE WAS NOT CAPTURED CORRECTLY THUS MAKING THE REPORTED EVENT DATES NOT POSSIBLE. THE CUSTOMER DID NOT RESPOND TO NUMEROUS ATTEMPTS TO CLARIFY. AWARE DATE UPDATED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 408359 AND LOT NUMBER 5204879. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, IT WAS VERIFIED THAT THE INFORMATION PRESENTED ON THE LABEL WAS IN ACCORDANCE WITH THE LABEL SPECIFICATIONS. A BARCODE READING WAS ALSO PERFORMED ON THE LABELS ATTACHED TO THE LOT HISTORY, AND THE READING WAS ALSO CONSISTENT WITH SPECIFICATIONS. THE REPORTED DEFECT COULD NOT BE IDENTIFIED THROUGH THE SAMPLE EVALUATION. BASED ON THE ANALYSIS OF THE PICTURE AND THE LABEL ATTACHED TO THE HISTORY OF THE LOT, THE PRODUCT IS WITHIN SPECIFICATIONS. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Description of Event or Problem
CUSTOMER REPORTED THAT THERE IS A DISCREPANCY IN THE EAN ON THE PHYSICAL IDENTIFICATION, SINCE EACH EAN CORRESPONDS TO A DIFFERENT SKU. CAN YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? ON (B)(6) 2026.
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.