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

Model Number A942216

Patient Problem Insufficient Information (4580)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

From staff: crna went to empty foley, upon opening drainage spout, foley bag opened at seam near spout.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 18684700
• MDR Text Key: 335115425
• Report Number: 18684700
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A942216
• Device Catalogue Number: A942216
• Device Lot Number: NGHW2268
• 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: 01/30/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 66 KG