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

Model Number A909216M

Device Problems Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Foley catheter bag was not draining appropriately.Nurse investigated and noticed that where the emptying spout connects to the front of the bag had also connected to the back wall of the bag.When pulled apart, it ripped a hole in the back of the bag.This is the second occurrence of the same situation on another patient on our unit.The first occurrence was considered an isolated issue.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 16292644
• MDR Text Key: 308734363
• Report Number: 16292644
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/19/2023

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: A909216M
• Device Catalogue Number: A909216M
• Device Lot Number: NGGX0896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female