MAUDE Adverse Event Report: C.R. BARD, INC.; ACCESSORIES, CATHETER

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

Event Type  malfunction  

Event Description

Foley catheter tubing noted to be leaking fluid from the clear disc directly below the blue access port. tubing was changed for a new set. unknown if any urine output was not recorded due to loss from the tube, although pt has had very low urine output.

• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 8273172
• MDR Text Key: 133953603
• Report Number: 8273172
• Device Sequence Number: 1
• Product Code: KGZ
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2018
• Date Report to Manufacturer: 01/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 DA