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

Model Number A942214

Device Problems Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Patient was being moved off the operating room table when it was noted that the foley catheter was not connected to the patient any longer.Staff tested the foley catheter balloon and noted a small hole in it.New foley catheter placed, and no patient harm.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 15378494
• MDR Text Key: 299474800
• Report Number: 15378494
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2022

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 Model Number: A942214
• Device Catalogue Number: A942214
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Sex: Female