MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Lot Number PD7600167

Patient Problem Insufficient Information (4580)

Event Date 08/16/2023

Event Type  malfunction  

Event Description

Per report entry: "patient ordered foley catheter placement.16f silicone foley inserted per order by two registered nurses (rns).Only about 40ml return received per nursing note.Patient later urinated but mostly around the catheter.No hematuria or visible clots.Md on call ordered foley exchange.New 16f foley inserted by two rns.40ml yellow urine return received.Patient later urinated but mostly around the catheter.Foley was irrigated by charge rn and resource rn, but urine continued to flow around the catheter.Again, no hematuria, clots or large sediment was returned.At this point, we were unable to determine the cause of the malfunction.Foley was removed and assessed by resource rn.Upon testing the balloon of the 16f foley that was removed, it was evident that the foley balloon was only inflating on one side of the catheter.Charge rn pulled another 16f from our par room and tested the balloon.Again only one side of the catheter balloon inflated.An 18f was then tested and the balloon inflated as normal.18f foley was placed and urine is now free flowing through the catheter without leakage".Unsure at time of report entry if unused same lot# catheters were returned to the manufacturer.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 17930300
• MDR Text Key: 325604529
• Report Number: 17930300
• Device Sequence Number: 1
• Product Code: MJC
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: PD7600167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32850 DA
• Patient Sex: Female
• Patient Weight: 55 KG