MAUDE Adverse Event Report: C.R. BARD, INC. LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY AND URINE METER; CATHETER, RETENTION TYPE, BALLOON

Model Number	303416A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse got a foley catheter insertion kit for a patient.When she opened the kit and checked the items inside, she noticed that the syringe used to inject water into the valve was uncapped and fluid was noted in the area surrounding the syringe.Note: the kit was discarded except for the syringe mentioned above.The cap was placed before submitting to risk manager to avoid spilling of the remaining fluid.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY AND URINE METER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 8949861
• Report Number: 8949861
• Device Sequence Number: 16761918
• Product Code: EZL
• UDI-Device Identifier: 00801741024726
• UDI-Public: (01)00801741024726(17)210930(10)NGDQ2739
• 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): 07/30/2019
• Report Date (Section F): 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Device Lot Number: NGDQ2739
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2019
• 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: 08/01/2019