Bard® Urinary Drainage Bag with Anti-Reflux Chamber

Description of Event or Problem

It was reported that the patient stated they were using foley catheter and Drainage Bag, Material# 897216. When patient lays in the bed with the drainage bag, it drains properly. When patient had it connected to the wheelchair it did not seem to drain into the bag properly. Per response notes, discussed a few ways to ensure proper drainage. Always keep drainage bag lower than the catheter and patient's bladder. This may require they secure bag in alternative places than what they are used to while keeping the bag off the floor. Never allow tubing to create dependent loops or become kinked. Also, to prevent or correct dependent loops, arrange the tubing so it ensures proper flow of urine into the drainage bag. Utilize the green sheeting clips to secure the tubing to the sheet. She states sometimes she lies the Drainage Bag flat. Discussed how this could cause the vent to get wet and reduce flow through the Drainage Bag. Discussed possibility of vapor lock and troubleshooting.

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. This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.