MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® I.C. COMPLETE CARE® FOLEY TRAY; CATHETER, UROLOGICAL, ANTIMICROBIAL

Model Number	300016A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Rn placed new foley catheter.Once inserted and balloon inflated, rn noticed that metal clip that drains urine from the collection bag was rusted.There was no moisture noted in the insertion kit.The bag was replaced with a new one.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Common Device Name: CATHETER, UROLOGICAL, ANTIMICROBIAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 7005956
• Report Number: 7005956
• Device Sequence Number: 2004896
• Product Code: MJC
• UDI-Device Identifier: 00801741000263
• UDI-Public: (01)00801741000263(17)190731(10)NGBS2850
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/31/2017
• Report Date (Section F): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/31/2019
• Device Model Number: 300016A
• Device Catalogue Number: 300016A
• Device Lot Number: NGBS2850
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO
• Date Report Sent to FDA: 10/31/2017