Onli

Description of Event or Problem

It was reported that the patient experienced urinary tract infections (UTIs) while using Hollister's Onli catherter. It was also reported that the catheter lubricant was thicker than normal and appeared gel-like rather than liquid and the patient associated the frequent UTIs with the thick lubricant.

Additional Manufacturer Narrative

A DHR review was conducted based on the lot number provided and the records were found to be complete and accurate. A review of production documentation, in-process and QAI inspection records, Gainseeker data, Finished Goods records, and sterilization documentation identified no abnormalities, non-conformances, or adverse trends related to the reported UTI. A root cause could not be determined. Hollister will continue to monitor this reported issue.