SPINAL/EPIDURAL NEEDLES & TRAYS
Received Apr 7, 2026 · Event occurred Mar 19, 2026
Report 9610048-2026-00050 · MDR key 24802272
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
401383
Lot number
5293229
Product problems
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1. ALL DEMOGRAPHIC INFORMATION ON THE REGULATORY DOCUMENT STATES "CONFIDENTIAL".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 WHEN OPENING THE TRAY FOR THE ANESTHESIOLOGIST, SHE NOTICED THE PRESENCE OF A FOREIGN BODY IN THE 1ML SYRINGE THAT IS PART OF THE DISPOSABLE SPINAL TRAY KIT, MAKING IT IMPOSSIBLE TO USE. ANOTHER TRAY HAD TO BE OPENED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: A REVIEW OF THE BATCH HISTORY, NONCONFORMANCE RECORDS, QUALITY NOTIFICATIONS RELATED TO THE REPORTED LOT, AND CORRECTIVE MAINTENANCE RECORDS WAS PERFORMED, AND NO RECORDS WERE IDENTIFIED THAT COULD BE ASSOCIATED WITH THE REPORTED DEFECT. ADDITIONALLY, THIS COMPLAINT DOES NOT INCLUDE SAMPLES OR PHOTOS FOR ANALYSIS, MAKING IT NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT. BASED ON THE INVESTIGATION CONDUCTED TO DATE, IT HAS NOT BEEN POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT. THE DEFECT WILL CONTINUE TO BE MONITORED THROUGH THE MONTHLY QUALITY DATA ANALYSIS (QDA) MEETINGS.
Description of Event or Problem
NO ADDITIONAL INFORMATION.