MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER; FOLEY TRAY

Catalog Number	902914
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.The device was not returned.
Event or Problem Description
It was reported that upon opening the tray, the betadine had leaked inside of the tray.
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 upon opening the tray, the betadine had leaked inside of the tray.
Additional Manufacturer Narrative
Received 1 opened foley tray system with the original unit packaging.The reported event was confirmed; however the cause is unknown.During visual inspection it was noted that the iodine packet had a tear on one side.The iodine leaked into the tray contents.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: "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).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 upon opening the tray, it was noted that the betadine leaked inside of the tray.

• Brand Name: BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6520617
• Report Number: 1018233-2017-02057
• Device Sequence Number: 1627104
• Product Code: EZC
• UDI-Device Identifier: 00801741024856
• UDI-Public: (01)00801741024856(10)NGAZ3695
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2017

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: 09/30/2018
• Device Catalogue Number: 902914
• Device Lot Number: NGAZ3695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 05/01/2017; 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1