inforMED
MalfunctionFCM

BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT

Received Jun 10, 2026 · Event occurred May 21, 2026

Report 1018233-2026-03748 · MDR key 25453168

Device

Generic name

Intermittent Catheter

Catalog number

4A5108

Lot number

NGKV3011

Product problems

  • Complete Blockage

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 THE INTERMITTENT CATHETER LUBRICANT WAS BLOCKING THE MIDDLE OF THE TUBING AND PREVENTING URINE FROM DRAINING, OR BECAUSE THE TUBE TIPS WERE BENT. LOT: NGKP3890 (X2), NGKS4681 (X2), NGKV3011 (X2), NGKW3221 (X2), NGKX2758 (X2).