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

Device Problems Fluid/Blood Leak (1250); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 8949861
• MDR Text Key: 156124202
• Report Number: 8949861
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741024726
• UDI-Public: (01)00801741024726(17)210930(10)NGDQ2739
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2019,07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Device Lot Number: NGDQ2739
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1