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

Model Number A903416A

Device Problems Inflation Problem (1310); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

From staff: it was noticed that the patient had not been putting out any urine.Rn attempted to manipulate the foley catheter.It was noticed that the catheter was no longer in the patient.The balloon was not inflated and the top on the catheter was partially detached.All parts of the catheter did come out of the patient.

• 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: 17370295
• MDR Text Key: 319486194
• Report Number: 17370295
• 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: 06/29/2023

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: A903416A
• Device Catalogue Number: A903416A
• 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: 06/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 86 KG