MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SURESTEP FOLEY TRAY - BARDEX I.C. WITH HYDROGEL AND BACTI-GUARD SILVER ALLOY; SURESTEP TRAY

Catalog Number	A303314A
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 water syringe was missing; however, none of the water leaked.The staff member that noticed the missing cap, used the tray; however, obtained a different water syringe as a precaution.No patient injury reported.
Additional Manufacturer Narrative
No physical sample was returned for evaluation.However, photo samples were received.Per the pictures provided, the reported issue could be confirmed that the cap of the water syringe was missing.Therefore the reported event was confirmed with an unknown cause.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.-attach the water filled syringe to the inflation port.-inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe." (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.Received photo sample only.
Event or Problem Description
It was reported that the cap of the water syringe was missing; however, none of the water leaked.The staff member that noticed the missing cap, used the tray; however, obtained a different water syringe as a precaution.No patient injury reported.

• Brand Name: SURESTEP FOLEY TRAY - BARDEX I.C. WITH HYDROGEL AND BACTI-GUARD SILVER ALLOY
• Common Device Name: SURESTEP TRAY
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6501016
• Report Number: 1018233-2017-01861
• Device Sequence Number: 16460819
• Product Code: MJC
• UDI-Device Identifier: 00801741073786
• UDI-Public: (01)00801741073786(17)181031(10)NGAX0398
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: 10/31/2018
• Device Catalogue Number: A303314A
• Device Lot Number: NGAX0398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1