MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®; CATHETER, RETENTION TYPE, BALLOON

Model Number A300416A

Device Problem Material Discolored (1170)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

When l&d rn opened a foley to insert in the operating room she noticed the tubing was discolored and not consistent throughout the tube.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 14572998
• MDR Text Key: 293153788
• Report Number: 14572998
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2022

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: Health Professional
• Device Model Number: A300416A
• Device Catalogue Number: A300416A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female