SURE STEP FOLEY TRAY SYSTEM A300316A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-25 for SURE STEP FOLEY TRAY SYSTEM A300316A manufactured by C.r. Bard Inc.

Event Text Entries

[26730502]
Patient Sequence No: 1, Text Type: N, H10

[26730503] On two separate occasions, two different employees attempted to empty the patient's foley bag and encountered a drainage clamp that was not catching which resulted in a urine splash to the employee's face. Employees with urine splash were exposed to the patient's body fluids and were referred to employee health.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5103496
• MDR Report Key: 5103496
• Date Received: 2015-09-25
• Date of Report: 2015-09-23
• Date of Event: 2015-09-16
• Report Date: 2015-09-23
• Date Reported to FDA: 2015-09-23
• Date Reported to Mfgr: 2015-09-23
• Date Added to Maude: 2015-09-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: CHRISTY LEWIS
• Manufacturer Street: 8195 Industrial Blvd.
• Manufacturer City: Covington GA 30014
• Manufacturer Country: US
• Manufacturer Postal: 30014
• Manufacturer Phone: 784-6370
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SURE STEP FOLEY TRAY SYSTEM
• Generic Name: BAG, URINE COLLECTION
• Product Code: NNW
• Date Received: 2015-09-25
• Catalog Number: A300316A
• Device Availability: Y
• Device Age: 1 DY
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: C.R. BARD INC
• Manufacturer Address: 730 CENTRAL AVE. MURRAY HILL, NJ 07974 US 07974

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-09-25