SPINAL/EPIDURAL NEEDLES & TRAYS
Received Feb 9, 2026 · Event occurred Jan 24, 2026
Report 9610048-2026-00019 · MDR key 24290699
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
408380
Lot number
5167400
Product problems
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 408380 AND LOT NUMBER 5167400. 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. PER THE REVIEW AND DOCUMENTATION, A DOCUMENT FORM WAS REVIEWED WHICH INCLUDES THE FIRST PRINTOUT OF THE LABEL FOR THE INVOLVED LOT. LABEL PRINTING CAN ONLY CONTINUE AFTER APPROVAL FROM THE QUALITY CONTROL INSPECTOR WHO CHECKS THE BARCODE READABILITY AND PERFORMS A VISUAL COMPARISON OF THE LABEL INFORMATION AGAINST THE DRAWING. ACCORDING TO THE RECORDED DOCUMENTATION, THE LABEL WAS APPROVED BY QUALITY CONTROL. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. WHEN EVALUATING THE LABEL SHOWN IN THE SAMPLE PICTURES AND COMPARING IT TO THE INTERNAL DRAWING, IT WAS VERIFIED THAT THE INFORMATION PRESENTED WAS IN COMPLIANCE. 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.
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
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
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.