NOT APPLICABLE
Received Jan 12, 2026 · Event occurred Dec 23, 2025
Report 2618282-2025-00154 · MDR key 24035873
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405081
Lot number
4344681
Product problems
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TWO PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE IMAGES SHOW A 27GA (GRAY) NEEDLE ALONG WITH ITS COMPONENTS (NEEDLE-HUB, STYLET-HANDLE, AND SHIELD). IN ONE PHOTO THE NEEDLE SEEMS TO BE BENT AND IN THE OTHER PHOTO THE NEEDLE AND/OR STYLET SEEM TO BE DAMAGED. THE REPORTED INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE MOST PROBABLE CAUSES OF A BENT NEEDLE AND DAMAGED SHIELD ARE ASSOCIATED WITH MANUFACTURING WHEN THE STYLET IS ASSEMBLED TO THE CANNULA, THE SHIELD IS INSTALLED ONTO THE CANNULA, AND THE COMPONENTS ARE UNLOADED FROM THE MACHINE. ADDITIONALLY, SHIELD DAMAGE MAY OCCUR DURING MANUAL STORAGE AND HANDLING OF THE NEEDLES FOLLOWING ASSEMBLY. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT IS REPORTED NEEDLE HAD PROTRUDED BEYOND THE SHEATH. INITIAL DESCRIPTION: THE DOCTOR UPON OPENING THE SPINAL NEEDLE PACKAGE, IT WAS FOUND THAT THE NEEDLE HAD PROTRUDED BEYOND THE SHEATH, AND IT HAD NOT BEEN USED YET. THE NEEDLE WAS INSIDE THE SHEATH WITHIN THE PACKAGING FROM THE BEGINNING.