MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number A319516AM

Device Problems Fluid/Blood Leak (1250); Unintended Deflation (4061)

Patient Problem Failure of Implant (1924)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Operating room nurse inserted foley without issues once patient was put under anesthesia.During the surgical case perfusion and anesthesia noted there was no urine output.Once operating room nurse had access to check under the drapes, the foley was found lying on the bed, not inside the patient.Foley was taken off the bed by operating room nurse and inspected.The balloon was reinflated with 10 cc of saline and operating room nurse observed the foley balloon slowly deflate over serval minutes.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 17071119
• MDR Text Key: 316611702
• Report Number: 17071119
• Device Sequence Number: 1
• Product Code: MJC
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A319516AM
• Device Catalogue Number: A319516AM
• Device Lot Number: NGHP0843
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female