inforMED
MalfunctionBSP

NEEDLE SPINAL S/SU 27GA 3-1/2IN QUINCKE

Received Jun 24, 2026 · Event occurred Jun 16, 2026

Report 3003152976-2026-00298 · MDR key 25610533

Device

Generic name

Needle, Conduction, Anesthetic (w/wo Introducer)

Catalog number

405081

Lot number

5100496

Product problems

  • Leak/Splash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED, NEEDLE SPINAL S/SU 27GA 3-1/2IN QUINCKE, LEAKAGE. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: THE STYLET OF SPINAL NEEDLE WAS FOUND TO BE LEAKING IN OPERATION ON TIME WITH THE CASE. ADDITIONAL PACKAGE NEED BE OPENED ADDITIONAL INFORMATION: I APOLOGIZE LOT NUMBER : 5100496 CAT#405081. THE LEAK AT THE CONNECTION POINT BETWEEN THE HUB AND THE SYRINGE. THE CUSTOMER USE SYRINGE SLIP TIP .

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. G.4. ADDITIONAL 510K: K210978.