MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER; CATHETER, COUDE

Model Number	A902916
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When the bard urinary catheter pack was opened, the green collection tube coming from the urinary bag had some white streaks on it.Another pack was opened and the same findings were noted.Both packs were brought to the quality department/ adverse event coordinator-reporter.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 17719067
• Report Number: 17719067
• Device Sequence Number: 20637881
• Product Code: EZC
• UDI-Device Identifier: 00801741074073
• UDI-Public: (01)00801741074073(17)250630(10)NGHQ0933
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/08/2023
• Report Date (Section F): 08/25/2023

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
• Device Model Number: A902916
• Device Catalogue Number: A902916
• Device Lot Number: NGHQ0933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/25/2023