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

Catalog Number	A319416AM
Health Effect - Clinical Code	Abdominal Distention (2601)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned; however, a photo sample was received.The reported event was confirmed per photographic inspection; however, the cause is unknown.The device was not returned for evaluation.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.-maintain unobstructed urine flow and keep the catheter and collection tube.-keep the collection bag below the level of the bladder or hips at all times.-empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient." (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 tubing of the drainage bag was kinked at the urine meter.As a result, urine leaked around the meatus.An ultra sound was performed to determine the cause of the leak, as the patient was sedated.The ultrasound concluded that the patient's bladder was distended.The catheter was replaced and no further medical intervention was required.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6576981
• Report Number: 1018233-2017-02473
• Device Sequence Number: 13701828
• Product Code: MJC
• UDI-Device Identifier: 00801741073861
• UDI-Public: (01)00801741073861(17)190430(10)NGAY3521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: A319416AM
• Device Lot Number: NGAY3521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention