inforMED
MalfunctionMZY

GRAFT,VASCULAR,STAINLESS STEEL TUNNELER

Received Aug 26, 2020 · Event occurred Jul 24, 2020

Report 10453679 · MDR key 10453679

Device

Generic name

Graft,vascular,stainless Steel Tunneler

Product problems

  • Detachment of Device or Device Component

Patient

23725 DA

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

PER MIDAS REPORT, BULLET ON THE WAREING TUNNELER DETACHED AFTER BEING INSERTED INTO PATIENT. AFTER INSPECTION, IT APPEARED ONE BALL BEARING THAT RETAINED THE BULLET TO THE TUNNELER WAS MISSING.

Description of Event or Problem

PER MIDAS REPORT, BULLET ON THE WAREING TUNNELER DETACHED AFTER BEING INSERTED INTO PATIENT. AFTER INSPECTION, IT APPEARED ONE BALL BEARING THAT RETAINED THE BULLET TO THE TUNNELER WAS MISSING.