inforMED
MalfunctionOFB

JELCO

Received Feb 1, 2021

Report 3012307300-2021-00538 · MDR key 11258282

Device

Generic name

Peripheral Intravenous Catheter

Catalog number

4030-AI

Product problems

  • Material Too Rigid or Stiff
  • Material Too Rigid or Stiff

Patient

Not reported

  • Vasculitis
  • Vasculitis

Narrative

Description of Event or Problem

INFORMATION WAS RECEIVED THAT DIFFICULTIES ARE BEING OBSERVED WITH INCREASED FREQUENCY WITH THE NEW JELCO. UPON PLACEMENT, DUE TO THE RIGIDITY OF THE MATERIAL, IT IS DISPLACED INTRAVENOUSLY AFTER THE PUNCTURE. IN MOST CASES THIS CAUSES THE RUPTURE OF THE VESSEL. ADDITIONALLY, SINCE USING THESE CATHETERS THE RATE OF PHLEBITIS HAS INCREASED.