MAUDE Adverse Event Report: C. R. BARD, INC. BARD CATHETER INSERTION KIT; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2021

Event Type  malfunction  

Event Description

Patient's foley came apart at green part.This is a safety issue for staff and it is not sterile and safe for patient.

• Brand Name: BARD CATHETER INSERTION KIT
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 13108510
• MDR Text Key: 282902031
• Report Number: 13108510
• Device Sequence Number: 1
• Product Code: MJC
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Race: Black Or African American