MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DRAIN BAG FOLEY TRAY WITH BARDEX® ALL-SILICONE CATHETER; SILOCNE CATHETER

Model Number	897516
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿balloon cuffing¿ with a potential root cause of "incorrect balloon position length due to the balloon was not stretched after balloon position".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: "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.".
Event or Problem Description
It was reported that the catheter was pulled out of the patient and was noted having a ridged ring around the end, which made it painful to remove for the patient.No medical intervention was reported.

• Brand Name: BARD® DRAIN BAG FOLEY TRAY WITH BARDEX® ALL-SILICONE CATHETER
• Common Device Name: SILOCNE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9232757
• Report Number: 1018233-2019-06732
• Device Sequence Number: 2588977
• Product Code: EZL
• UDI-Device Identifier: 00801741025020
• UDI-Public: (01)00801741025020
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: 897516
• Device Catalogue Number: 897516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1