MAUDE Adverse Event Report: C. R. BARD, INC. BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER; CATHETER, UROLOGICAL

Model Number	772415
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
2 straight cath kits stated they had (2) non latex, sterile gloves in the package and did not have the gloves in the package.

• Brand Name: BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10754629
• Report Number: 10754629
• Device Sequence Number: 3246410
• Product Code: KOD
• UDI-Device Identifier: 00801741030413
• UDI-Public: (01)00801741030413
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2020
• Report Date (Section F): 10/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: 772415
• Device Catalogue Number: 772415
• Device Lot Number: NGET3669
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/12/2020