MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY AND URINE METER; FOLEY TRAY

Model Number	303416A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Discomfort (2330); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the lubricant cap of the syringe was expelled during urination.The catheter had been placed during a vaginal delivery, after the patient had received an epidural.The patient had discomfort upon urination.A small plastic object, 6 x 12 mm in size, was expelled.The complainant stated that it would be helpful if the cap of the lubricant was not clear, but instead a color.Additional information was received, via email, from the complainant on (b)(6) 2018.The cap fell out of the patient approximately 2 weeks prior to her post partum check on (b)(6) 2018.The patient urinated the cap out.The lubricant was placed in the tray, and the catheter placed into the lubricant before insertion.
Additional Manufacturer Narrative
The reported event was confirmed to be user-related based of the event description.No sample was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." the device was not returned.
Event or Problem Description
It was reported that the lubricant cap of the syringe was expelled during urination.The catheter had been placed during a vaginal delivery, after the patient had received an epidural.The patient had discomfort upon urination.A small plastic object, 6 x 12 mm in size, was expelled.The complainant stated that it would be helpful if the cap of the lubricant was not clear, but instead a color.Additional information was received, via email, from the complainant on 21-nov-2018.The cap fell out of the patient approximately 2 weeks prior to her post partum check on 5-oct-2018.The patient urinated the cap out.The lubricant was placed in the tray, and the catheter placed into the lubricant before insertion.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY AND URINE METER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8137208
• Report Number: 1018233-2018-05877
• Device Sequence Number: 13893092
• Product Code: EZL
• UDI-Device Identifier: 00801741024726
• UDI-Public: (01)00801741024726
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 303416A
• Device Catalogue Number: 303416A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1