MAUDE Adverse Event Report: C. R. BARD, INC. BARD URINE METER FOLEY CATHETER TRAY WITH BARDEX ALL-SILICONE CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 902416

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

When setting up for sterile foley catheter placement, noted that the sterile gloves in kit were brown on edges on right glove.Entire kit saved for management follow up and new kit was used for patient.

• Brand Name: BARD URINE METER FOLEY CATHETER TRAY WITH BARDEX ALL-SILICONE CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12057126
• MDR Text Key: 258052178
• Report Number: 12057126
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/21/2021

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 Operator: No Information
• Device Model Number: 902416
• Device Catalogue Number: 902416
• Device Lot Number: NGEU2789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1