MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®

Model Number	A303414A
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 seal was broken on the packaging of the tray.
Additional Manufacturer Narrative
The reported issue was unconfirmed, as the problem could not be reproduced.During visual evaluation, it was observed that the package was open by the breather strip, and the bag had evidence of transference of seal in a section of the seal of the breather strip.The seal performed by manufacture and the side seals of supplier were evaluated thoroughly under a magnifying lamp 20x and found no drilling in the packaging, pleats, interruptions in the seal or any damages that may contribute to the problem reported.During the functional evaluation, the manufacturing seal and side seals of supplier were evaluated.Blue methylene was injected into the packaging per the methylene blue seal integrity dye test, and no presence of methylene blue was found on the seal area of manufacturing seal or the supplier side seals.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.".
Event or Problem Description
It was reported that the seal was broken on the packaging of the tray.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• 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: 6592990
• Report Number: 1018233-2017-02688
• Device Sequence Number: 662212
• Product Code: MJC
• UDI-Device Identifier: 00801741073816
• UDI-Public: (01)00801741073816(17)190430(10)NGBN2248
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K984136
• 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): 07/20/2017

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: 04/30/2019
• Device Model Number: A303414A
• Device Catalogue Number: A303414A
• Device Lot Number: NGBN2248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1