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

Model Number A119216M

Device Problems Device Dislodged or Dislocated (2923); Unintended Deflation (4061)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Foley was placed by operating room rn around 1115, around 1255 it was discovered that the foley catheter was no longer inside the bladder.Balloon was filled with 10cc of air to check for hole.No obvious signs of holes.After syringe was removed, the catheter balloon slowly deflated.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® TEMP 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: 16408509
• MDR Text Key: 309890900
• Report Number: 16408509
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2022

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: A119216M
• Device Catalogue Number: A119216M
• Device Lot Number: PK7645826
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male