MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 175816

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Registered nurse (rn) placed foley catheter, urine return noted, balloon inflated with 10cc syringe.Rn placed catheter bag at end of bed.Rn went to reposition patient and noticed foley catheter tubing was severed from the foley balloon and laying in patient's bed.The tubing was found to be sliced in half, which left the tip of the foley along with the balloon inside of the patient.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 17641086
• MDR Text Key: 322157061
• Report Number: 17641086
• 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: 08/15/2023

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 Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGHQ2185
• 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: 08/15/2023
• Date Report to Manufacturer: 08/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA