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

Model Number	902914
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 cap of the lubrication syringe came off and the lubricant leaked throughout the tray making it unusable.Per the sample evaluation, it was noticed that the syringe cap was missing from the tray.
Additional Manufacturer Narrative
The reported issue was confirmed after visual evaluation.During visual inspection, it was noted that the lubricant leaked in the tray.The syringe did not have the cap on the tip.The cap was not returned with the received sample.The reported lot is applicable to the catheter and the end item lot could not be known by this information; therefore, the device history record could not be reviewed.The instructions for use state the following: ¿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." 2306, 2645: "nl".
Event or Problem Description
It was reported that the cap of the lubrication syringe came off and the lubricant leaked throughout the tray making it unusable.Per the sample evaluation, it was noticed that the syringe cap was missing from the tray.
Additional Manufacturer Narrative
Received 1 opened foley tray.The reported issue was confirmed.During visual inspection, it was noted that the lubricant leaked in the tray.The syringe did not have the cap on the tip.The cap was not returned with the received sample.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: ¿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." (b)(4).
Event or Problem Description
It was reported that the cap of the lubrication syringe came off and the lubricant leaked throughout the tray making it unusable.

• Brand Name: BARD® URINE METER FOLEY CATHETER 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: 6727223
• Report Number: 1018233-2017-03830
• Device Sequence Number: 670518
• Product Code: EZC
• UDI-Device Identifier: 00801741024856
• UDI-Public: (01)00801741024856
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2017

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 Model Number: 902914
• Device Catalogue Number: 902914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 09/14/2017; 10/03/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/20/2017; 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1