Adverse Events Associated With Female External Urinary Collection Devices.

Importance: Female external urinary collection devices were designed with the goal of decreasing the risk of catheter-associated urinary tract infections, which can have significant clinical complications. The BD PureWick urinary collection system, C. R. Bard, Inc., a wholly owned subsidiary of BD, Franklin Lakes, NJ, was the first device to enter the market and has had a widespread distribution. There is a lack of clinical data evaluating the safety of the PureWick device.

Objectives: This study aimed to evaluate adverse events associated with the PureWick device using reports from the U.S. Food and Drug Administration Manufacturer and User Device Experience database.

Study design: A retrospective case series was conducted of adverse events from the database, which includes the adverse events and patient demographics from mandatory and voluntary reporters. Grounded theory was applied, utilizing inductive reasoning to identify salient keywords in the analysis of adverse events.

Results: A total of 1,406 reports were submitted to the database from January 2016 to October 2023, with each report having at least 1 adverse event complaint. Report complaints were classified by patient injury (n = 1412, 67.6%), device malfunction (n = 459, 22.1%), user error (n = 125, 6.0%), device instructions (n = 83, 4.0%) and death (n = 6, 0.29%). Salient keywords include urinary tract infection, skin irritation, and device leakage.

Conclusions: There are adverse events associated with the PureWick external urinary collection device in reports from the U.S. Food and Drug Administration database. These findings warrant additional studies to assess the safety of the PureWick for patients using the device in the hospital and at home.