inforMED
MalfunctionBSP

PENCAN SPINAL NEEDLE TRAY

Received Feb 25, 2026 · Event occurred Jan 26, 2026

Report MW5184384 · MDR key 24443516

Device

Generic name

Needle, Conduction, Anesthetic (w/wo Introducer)

Lot number

0062041185

Product problems

  • Defective Device
  • Temperature Problem

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

FOLLOWING TWO SURGICAL PROCEDURES UTILIZING THIS SUPPLY SPINAL TRAY FOR SPINAL ANESTHESIA, IT WAS NOTED THE LOCAL WAS INEFFECTIVE. ONE CASE PROCEEDED TO GENERAL ANESTHESIA AND ANOTHER FOR REPEAT SPINAL UTILIZING LOCAL PULLED FROM LOCAL PHARMACY (NOT THE LOCAL CONTAINED IN THE KIT). NO PATIENT HARM, HOWEVER CONCERN OF THE EFFICACY WITHIN THE KIT OF THE LOCAL. UNCLEAR IF THE LOCAL WAS AFFECTED DURING TRANSPORTATION AS THERE WERE EXTREME TEMPERATURE FLUCTUATIONS WITHIN THE REGION PRIOR TO THESE TWO EVENTS. WE DID CROSS-CHECK WITH THE VENDOR & LOCAL TRANSPORTATION AND NOTED TEMPERATURE CONTROLS MAINLINED TO PROTECT THE INTEGRITY OF THE LOCAL INSIDE THE KIT. BEING A SUPPLY, THE SPINAL TRAYS/LOCAL INSIDE ARE NOT SCANNED INTO THE MEDICAL RECORD SO CANNOT LINK THE SPECIFIC MEDICATION TO THE PATIENT, HOWEVER, FOLLOWING INVESTIGATION, PROVIDER TECHNIQUE WAS RULED OUT. PER REVIEW, TEAMS QUESTION THE EFFICACY OF THE LOCAL. ENTERING REPORT FOR AWARENESS AND IF OTHER NOTED POTENTIAL CONCERNS OF THE LOCAL EFFICACY WITHIN THIS SUPPLY. PT CODE: 4580. DEVICE CODES: 3022, 2588. REFERENCE REPORT MW5184385.