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

Model Number 175816

Device Problem Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 02/18/2022

Event Type  malfunction  

Event Description

The balloon located near the tip of the bd lubri-sil¿ foley catheter folded/thickened, despite [balloon] being completely deflated, causing painful removal.

• 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: 13757265
• MDR Text Key: 287129147
• Report Number: 13757265
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGFZ0871
• 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: 03/01/2022
• Date Report to Manufacturer: 03/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA