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

Model Number	800361
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the tip of the lubricant syringe in the lubricant foley tray was broken.The lubricant within the syringe dried and turned yellow.There were no reports of leakage within the tray.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened, unused surestep foley tray.It was noted that the lube syringe was broken with a missing tip and contained an orange gel characteristic of the lubricant drying.The edges of the syringe tip were noted to be jagged.The break on the lube syringe barrel was out of specification.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: 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." h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the tip of the lubricant syringe in the lubricath foley tray was broken.The lubricant within the syringe dried and turned yellow.There were no reports of leakage within the tray.

• Brand Name: BARD® FOLEY TRAY WITH BARD® HYDROPHILIC-COATED FOLEY CATHETER
• Common Device Name: LUBRICATH FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8294034
• Report Number: 1018233-2019-00540
• Device Sequence Number: 11207613
• Product Code: EZC
• UDI-Device Identifier: 00801741040313
• UDI-Public: (01)00801741040313
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 04/25/2019

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: 11/30/2020
• Device Model Number: 800361
• Device Catalogue Number: 800361
• Device Lot Number: NGCT1703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1