MAUDE Adverse Event Report: C. R. BARD, INC. BARD FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Lot Number NGHY1216

Patient Problem Insufficient Information (4580)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

From staff: foley catheter inserted post epidural for labor, once inserted and syringe with saline from kit used to inflate catheter balloon, syringe started leaking around bottom of syringe.The syringe was leaking the saline close to where syringe and plunger connect, not where syringe attaches to foley catheter.

• Brand Name: BARD 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: 19124286
• MDR Text Key: 340369956
• Report Number: 19124286
• 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: 03/21/2024

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 Lot Number: NGHY1216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 73 KG