MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX I.C. COMPLETE CARE FOLEY CATHETER TRAY AND URINE METER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number 303316A

Device Problems Defective Component (2292); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

This was the first time i have used the new bardex i.C.Complete care foley kit and i noticed the 3 antiseptic swab sticks are very sticky and don't have a lot of betadine on them to where it was very difficult/almost impossible to prep the patient's genitalia with the prep sticks as directed by manufacturer's instructions.No product sample provided/saved.

• Brand Name: BARDEX I.C. COMPLETE CARE FOLEY CATHETER TRAY AND URINE METER
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12376931
• MDR Text Key: 268449095
• Report Number: 12376931
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 303316A
• Device Catalogue Number: 303316A
• Device Lot Number: NGFQ3521
• 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: 08/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1