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

Model Number 175816

Device Problems Deflation Problem (1149); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

Rn attempted to remove foley catheter but met resistance.Urology technician called to assist.Upon catheter removal, it was noticed that foley balloon did not deflate properly, causing a "lip" to form.Per urology technician, no harm to patient.Was or will be returned by supply chain management.

• 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: 14415658
• MDR Text Key: 291816852
• Report Number: 14415658
• 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: 05/04/2022

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 Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGGN3418
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1