MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD BILEVEL (UNIVERSAL) FOLEY CATHETERIZATION PROCEDURE TRAY WITHOUT; CATHETER TRAY

Catalog Number	782102
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 syringe was only half full with liquid.The cap was allegedly on the device when the tray was opened.No patient involvement was reported.
Additional Manufacturer Narrative
Received one opened foley catheterization tray with the original unit packaging.The reported event was confirmed with an unknown cause.The syringe was received empty and without the grey cap.The barrel was inspected for cracks and was not noted to have any defect in the barrel which caused leakage of water.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: "contents: uro-prep¿ tray with: underpad, drape povidone-iodine solution npn 02076144 30cc syringe (prefilled with sterile water) to inflate foley catheter only.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to 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 the syringe was only half full with liquid.The cap was allegedly on the device when the tray was opened.No patient involvement was reported.

• Brand Name: BARD BILEVEL (UNIVERSAL) FOLEY CATHETERIZATION PROCEDURE TRAY WITHOUT
• Common Device Name: CATHETER TRAY
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6510892
• Report Number: 1018233-2017-01955
• Device Sequence Number: 18835813
• Product Code: KNX
• UDI-Device Identifier: 00801741029639
• UDI-Public: (01)00801741029639(17)190331(10)NGAY2571
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Home Health Aide
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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: Other
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 782102
• Device Lot Number: NGAY2571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1