inforMED
MalfunctionMPB

NIAGARA

Received May 12, 2026 · Event occurred Apr 20, 2026

Report 3006260740-2026-03322 · MDR key 25152315

Device

Generic name

Acute Dialysis Catheter

Model number

NA

Catalog number

5594150

Lot number

REKN3510

Product problems

  • Product Quality Problem
  • Material Deformation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT ON APRIL 20, DURING INTUBATION, THE DOCTOR INDICATED THAT THIS GUIDE WIRE HAD NO ELASTICITY AND COULD NOT BE PULLED OUT. THE CATHETER COULD NOT BE USED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IT WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.