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

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2023

Event Type  malfunction  

Event Description

While attaching the syringe to obtain the urine from the sample attached to the urinary catheter came off and urine was leaking.

• Brand Name: INDWELLING URINARY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 16806112
• MDR Text Key: 313918491
• Report Number: 16806112
• 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: 04/14/2023

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
• 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: 04/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1