SPINAL NEEDLE 18GA 3.00 IN
Received Aug 15, 2025 · Event occurred Jul 1, 2025
Report 3003152976-2025-00449 · MDR key 22814755
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405247
Lot number
2010009
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION: THE GREEN PARTICLE WAS OBSERVED IN ITS FINAL PACKAGING (TRANSFER BAG), TOGETHER WITH THE ACTIVE SUBSTANCE AND ITS EXCIPIENTS.
Additional Manufacturer Narrative
(B)(4) FOLLOW UP MDR FOR CORRECTION. CORRECTION: THIS COMPLAINT WAS DETERMINED TO NOT BE A REPORTABLE EVENT AFTER THE MDR WAS SUBMITTED. THE GREEN PARTICLE WAS NOTED WITHIN THE BAG, NOT THE FLUID PATHWAY.
Additional Manufacturer Narrative
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: IDENTIFICATION OF A PARTICLE IN THE FINISHED PRODUCT. I AM CONTACTING YOU AS PART OF A QUALITY INVESTIGATION. DURING THE INSPECTION OF OUR LATEST PRODUCTION BATCH (DISTRIBUTED IN BAGS), WE NOTICED THE PRESENCE OF A GREEN PARTICLE MEASURING 2.24 MM. THIS PARTICLE WAS IDENTIFIED BY IR AND IS COMPOSED OF POLYCARBONATE.