MAUDE Adverse Event Report: C. R. BARD, INC. PUREWICK MALE EXTERNAL CATHETER KIT; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

Model Number PWM030

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

Manufacturer instructions does not address the need to disconnect the purewick from suction.There are instances where this device would need to be disconnected from suction in a real life situation such as therapy, ambulation, transporting to and from imaging.In these cases, we cannot look at the manufacturer instructions for any guidance for what to do.If we just disconnect the tubing, it can lead to the urine coming out of the device if the patient voids which is a possibility since these can be used for incontinence management.This leads to our nurses trying to get creative to solve the problem of dribbling or flow of urine.The most logical idea being, plug the port so urine doesn¿t come out and hook back up to suction upon return.Would like to be able to unhook purewick from suction to move patient with therapy.Currently there are no guidelines in the manufacturer instructions on how to do that.No way to cap or plug the purewick so either the urine leaks out the bottom of the purewick while the patient is up or we need to take off and put a new purewick on after which could cause skin issues and excessive use of supplies leading to increased cost & waste.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER KIT
• Type of Device: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 16536710
• MDR Text Key: 311219941
• Report Number: 16536710
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2023,03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PWM030
• Device Catalogue Number: PWM030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1