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

Model Number 175816

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

An elderly male being prepped a-fib ablation.Intubated, sedated - during foley catheter placement he developed trauma of his urethral tract.Rn inserting 16f catheter which advanced into urethra without resistance, but rn did not note a urine return.Catheter removed slightly and rn noted blood in catheter as well as blood surrounding catheter.Rn stopped removal and called doctor from urology to assist.Md removed initial catheter and inserted coudé.Patient transported to post-anesthesia care unit (pacu); patient educated on events.Urology: patient has urethral tear.Urology consult noted : patient had a 16 french silicone catheter in the urethra with the catheter having curled in the tip coming out of the meatus.This was carefully removed.A urojet was then used to instill and fill the urethra with lidocaine jelly.A 16 french coudé-tip catheter was then used and with several manipulations was eventually able to be advanced into the bladder.Clear yellow urine drained at that time.Balloon was inflated and the catheter was put to drainage bag.At that point there was no active bleeding from the urethra.

• 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: 14601263
• MDR Text Key: 293344616
• Report Number: 14601263
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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
• 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: 06/02/2022
• Device Age: 0 YR
• Event Location: Other
• Date Report to Manufacturer: 06/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26645 DA
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White