MAUDE Adverse Event Report: C.R. BARD, INC. SURE STEP FOLEY TRAY SYSTEM; BAG, URINE, COLLECTION

Catalog Number A303416A

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 12/15/2015

Event Type  malfunction  

Event Description

Rn reported bard stat lock to secure indwelling catheter was occluding the flow of urine into the urine meeter, as if it was clamped.The nurse reported 45 cc urine came out once the stat lock removed.She then used taped on the leg instead.The leg securement device called stat lock is part of the foley tray system.Manufacturer response for 16 fr sure step foley tray system, sure step foley tray system/ bard medical (per site reporter): the end user is not applying the tubing into the stat lock as instructed.There is only one way to put the tubing into the securement device and if the user puts tubing in the opposite direction this will crimp or occlude the outflow of urine.

• Brand Name: SURE STEP FOLEY TRAY SYSTEM
• Type of Device: BAG, URINE, COLLECTION
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington, GA 30014
• MDR Report Key: 5531183
• MDR Text Key: 41313780
• Report Number: 5531183
• Device Sequence Number: 1
• Product Code: NNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: A303416A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2016
• Device Age: 0 DY
• Event Location: Other
• Date Report to Manufacturer: 03/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR