MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE; CATHETER, RETENTION TYPE, BALLOON

Model Number	A303416A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Circulating rn inserted 16 fr foley catheter using sterile technique, without resistance.10cc balloon inflated with 10 ml sterile water.Rn noted balloon port to be slowly and steadily leaking water after removal of syringe.Balloon deflated (9 ml water removed) and foley catheter removed.New 16 fr foley package opened and inserted.No leaking noted upon balloon inflation with sterile water.Leaking balloon port--surestep foley tray system (ref.A303416a) (possible lot #pk7662511 or #pk7645844) no known injury to patient occurred.Malfunctioning foley catheter was replaced immediately.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 20199322
• Report Number: 20199322
• Device Sequence Number: 15333020
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: (01)00801741073823
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/25/2024
• Report Date (Section F): 04/25/2024

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: A303416A
• Device Catalogue Number: A303416A
• Device Lot Number: PK7662511 OR PK7645844
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/25/2024