inforMED
MalfunctionMPB

NIAGARA SLIM-CATH

Received Jul 8, 2026 · Event occurred Jun 21, 2026

Report 3006260740-2026-04801 · MDR key 25752212

Device

Generic name

Catheter, Hemodialysis, Non-implanted

Model number

N/A

Catalog number

5553200

Lot number

REKR0750

Product problems

  • Fluid/Blood Leak

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

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 WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

Description of Event or Problem

IT WAS REPORTED PROFESSOR FROM THE MEDICAL COLLEGE EXPERIENCED FLUID LEAKAGE DURING THE IMPLANTATION OF A SHORT-TERM CATHETER. NO FURTHER INFORMATION WAS PROVIDED.