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

Model Number	899616
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that the betadine within the tray had leaked all over the inside of the tray.
Additional Manufacturer Narrative
Based on the reported issue (it was reported that the betadine within the tray has leaked all over inside the tray.) was confirmed, as supplier related: (b)(4) during visual inspection noted the iodine appeared to leak through the tray; it was observed that the iodine was not completely sealed on the upper part.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿direction for use: visually inspect the product for any imperfections or surface deterioration prior use.If the package is opened or if any imperfection surface is observed, do not use it." (b)(4).
Event or Problem Description
It was reported that the betadine within the tray had leaked all over the inside of the tray.

• Brand Name: BARD® FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6819934
• Report Number: 1018233-2017-04437
• Device Sequence Number: 16264193
• Product Code: EZC
• UDI-Device Identifier: 00801741000287
• UDI-Public: (01)00801741000287
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: 02/28/2019
• Device Model Number: 899616
• Device Catalogue Number: 899616
• Device Lot Number: NGAY0314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1