NIAGARA SLIM-CATH
Received Jun 5, 2026 · Event occurred May 21, 2026
Report 3006260740-2026-03930 · MDR key 25410407
Device
Generic name
Acute Dialysis Catheter
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
5553200
Lot number
REKR0750
Product problems
- Crack
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 ON MAY 21, DURING CATHETER PLACEMENT, FLUID LEAKAGE WAS OBSERVED FROM THE PRE FILLED INTRODUCER NEEDLE. THE CATHETER WAS SUBSEQUENTLY REINSERTED TO MEET THE PATIENT¿S TREATMENT NEEDS. NO FURTHER INFORMATION WAS PROVIDED.