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

Model Number 942216

Device Problem Fluid/Blood Leak (1250)

Patient Problem Urinary Retention (2119)

Event Date 12/23/2022

Event Type  malfunction  

Event Description

Insertion of indwelling foley catheter was order secondary to (2/2) patient urinary retention and the need for 3 previous straight catheterizations to drain bladder.Inserted indwelling foley per protocol.Picked up bag to hang on side of bed it was noted the bag was wet.Dried the bag and upon close inspection it was found to be leaking urine.No visible holes noted.Notified covering physician.Was advised to open sealed connection between the catheter and drainage bag to exchange the bag only.Cleaned the tubing at connection site with chg wipes, applied sterile gloves and exchanged the drainage bag.

• Brand Name: BARD® URINE METER FOLEY TRAY WITH 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: 16452016
• MDR Text Key: 310335295
• Report Number: 16452016
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 942216
• Device Catalogue Number: 942216
• Device Lot Number: PD7500767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Female