MAUDE Adverse Event Report: C. R. BARD, INC. BARD® SILASTIC® FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	33618
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Specific event type: supply issue.Person affected: not associated with a person.Severity level: good catch.Injury incurred? no.Equipment/product involved/malfunctioned? yes.Brief factual description: silastic foley catheters have excess powder look material around foley connecter area, and yellow discolored substance around foley catheter hole area.Multiple foley catheter packages are opened to find acceptable catheter.Doctor decided to use latex free catheters for his procedures.Contributing factors (reported): none/unknown.Immediate actions (reported); used latex free foley catheter.Manufacturer response for catheter, retention type, balloon, bard® silastic® foley catheter (per site reporter).Or service leader called our bard rep.[date redacted] and is waiting for return phone call.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 22838336
• Report Number: 22838336
• Device Sequence Number: 9410510
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/17/2025
• Report Date (Section F): 07/17/2025

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: 33618
• Device Catalogue Number: 33618
• Device Lot Number: NGJX4260
• 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: 08/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• 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: 07/17/2025