MAUDE Adverse Event Report: C.R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM; CATHETER, RETENTION TYPE, BALLOON

Model Number "A897516"

Device Problems Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/31/2022

Event Type  Injury  

Event Description

Upon removing catheter, met with resistance.Once removed a ridge was visible on the catheter.Similar event with same product and errors 5/17/2022.

Event Description

Upon removing catheter, met with resistance.Once removed a ridge was visible on the catheter.Similar event with same product and errors (b)(6) 2022.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 14601883
• MDR Text Key: 293502465
• Report Number: MW5110113
• 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
• Type of Report: Initial
• Report Date: 06/02/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: "A897516"
• Device Lot Number: N66P3690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1