MAUDE Adverse Event Report: C. R. BARD, INC. BARD URINE METER FOLEY CATHETER TRAY WITH BARDEX LUBRICATH FOLEY CATHETER; CATHETER, COUDE

Model Number 304916

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2023

Event Type  malfunction  

Event Description

Sampling port fell off drainage bag.

• Brand Name: BARD URINE METER FOLEY CATHETER TRAY WITH BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 16501230
• MDR Text Key: 310889620
• Report Number: 16501230
• Device Sequence Number: 1
• Product Code: EZC
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 304916
• Device Catalogue Number: 304916
• Device Lot Number: NGGU0232
• 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: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 74 KG