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

Model Number 1758SI16

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

Patient's foley catheter was ordered to be removed.When attempting to remove the catheter, resistance was met and was unable to be removed.Once removed, the balloon of the catheter appeared to be "rolled" even though the balloon was emptied prior to removal.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: 16435201
• MDR Text Key: 310161476
• Report Number: 16435201
• 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: 01/30/2023

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: 1758SI16
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGGVO199
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Sex: Male
• Patient Weight: 98 KG