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

Model Number 897216

Device Problem Defective Device (2588)

Patient Problem Urinary Retention (2119)

Event Date 11/19/2020

Event Type  malfunction  

Event Description

Bard latex-free foley catheter, lot # ngev1612, exp date: 3/31/2023 placed.Labor nurse checked output an hour later and visualized clear light yellow urine in the tubing but no urine draining into foley bag.Patient had been voiding frequently prior to foley placement.Foley bag switched out for urometer bag with immediate drainage of large amount of urine.Foley bag appears to have membrane covering opening into bag that will not allow urine to drain through.

• Brand Name: BARD FOLEY TRAY WITH BARDEX ALL SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 1211 mary magnan blvd; madison GA 30650
• MDR Report Key: 10991267
• MDR Text Key: 220920000
• Report Number: 10991267
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/25/2020

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: No Information
• Device Model Number: 897216
• Device Catalogue Number: 897216
• Device Lot Number: NEGEV1012
• 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: 11/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7665 DA
• Patient Weight: 113