MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER

Model Number	A319416AM
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 tubing that connects to the urimeter kinked.
Additional Manufacturer Narrative
The reported issue was confirmed during visual evaluation.During visual inspection it was noted the drainage tubing was kinked.The kink in the drainage tube was located approximately ½ in above the urine meter.The inspection procedure to product a319416am specified in the visual requirements ¿kinks in drainage tube, are not permitted." the id and od of the drainage tube were measured in the section free of kink, under specification (b)(4), rv3 and were found to be within specification.However the root cause of the kinked in the drainage tube could not be determined.The pattern of folding was not possible reviewed because the sample was received without it's original package.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.-maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.-keep the collection bag below the level of the bladder or hips at all times.-position hanger on bed rail at the foot of the bed -use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked." (b)(4).
Event or Problem Description
It was reported that the tubing that connects to the urimeter kinked.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE 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: 6602890
• Report Number: 1018233-2017-02832
• Device Sequence Number: 11037092
• Product Code: MJC
• UDI-Device Identifier: 00801741073861
• UDI-Public: (01)00801741073861
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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
• Report Date (Section B): 08/18/2017

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: A319416AM
• Device Catalogue Number: A319416AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1