MAUDE Adverse Event Report: C. R. BARD, INC. BARD 16FR SURE STEP FOLEY TRAY SYSTEM; CATHETER RETENTION TYPE BALLOON

Model Number MT 3750825

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

I was given 1 each of cat # a300316a (mt # 3750825) tray cath 16f last week.It has what looks to be a dead bug inside of the packaging.

• Brand Name: BARD 16FR SURE STEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER RETENTION TYPE BALLOON
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 8565198
• MDR Text Key: 143681459
• Report Number: MW5086265
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

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
• Device Operator: Health Professional
• Device Model Number: MT 3750825
• Device Catalogue Number: A300316A
• Device Lot Number: NGCX1600
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1