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

Model Number	772514
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Bard latex-free urethral catheterization tray with pre-connected bag malfunctioned when rn was performing straight catheterization on patient.Collection bag leaked around air vent r/t tear in plastic.This was reported to me by the rn using the kit.Rn also shared that the patient stated that a similar leak had happened previously when another rn performed a straight catheterization.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7582035
• Report Number: 7582035
• Device Sequence Number: 1524226
• Product Code: KOD
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018
• Report Date (Section F): 05/31/2018

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: Nurse
• Device Model Number: 772514
• Device Catalogue Number: 772514
• Device Lot Number: NGBZ2719
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2018
• 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: 05/31/2018