BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
Received Jun 2, 2026 · Event occurred May 25, 2026
Report 1018233-2026-03549 · MDR key 25367870
Device
Generic name
Dilation Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
996081
Lot number
BMJYFM04
Product problems
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS LOSS OF PRESSURE DURING BALLOON PRESSURIZATION, LEAKAGE OF BALLOON FOUND, REPLACEMENT OF BALLOON USE.