MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER; SURESTEP FOLEY TRAY

Model Number	A899916
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened received tray in open original package, sticky amber substance inside tray near lubricant syringe.Although the reported event was confirmed, the root cause could not be determined.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: warning: on catheter, do not use ointments or lubricants having a petroleum base.They will damage the catheter and may cause balloon to burst.Visually inspect the product or 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 brown foreign material was inside of the surestep foley tray and on the tip of the lubricant syringe.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: SURESTEP FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8761205
• Report Number: 1018233-2019-03642
• Device Sequence Number: 2040246
• Product Code: EZC
• UDI-Device Identifier: 00801741074011
• UDI-Public: (01)00801741074011
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

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 Expiration Date: 03/31/2021
• Device Model Number: A899916
• Device Catalogue Number: A899916
• Device Lot Number: NGCX2772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1