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

Model Number A897516

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

After removing all of the fluid from the balloon, attempted to remove the catheter and felt resistance.Physician called to remove catheter, upon removal, it was noticed that the balloon had created a ring on the catheter.Blood noted on catheter at that time and report done.Manufacturer response for catheter, retention type, balloon, (surestep foley tray system) (per site reporter).Complaint report created.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARDEX ALL- SILICONE 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: 14266026
• MDR Text Key: 290533508
• Report Number: 14266026
• 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: 04/22/2022,04/21/2022

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 Model Number: A897516
• Device Catalogue Number: A897516
• Device Lot Number: NGFY4417
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86 KG