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

Model Number A300316A

Patient Problem Failure of Implant (1924)

Event Date 11/21/2023

Event Type  Injury  

Event Description

85 year old female with an indwelling foley catheter (16 french, 5 ml bulb).She reported that on (b)(6) 2023 she felt a ¿pop" inside her bladder.She began leaking urine onto the bed.The nurse inserted a new 16 french foley, 5 ml bulb.On (b)(6) 2023, the resident reported her catheter was out and on the bed.The bulb was intact and there was no bleeding at the meatus.A new 16 french foley with a 5 ml bulb was placed and there was immediate return of cloudy yellow urine with sediments in the bedside drainage bag.The foley catheters were discarded.

• Brand Name: BARD SURESTEP FOLEY TRAY SYSTEM BARDEX IC COMPLETE CARE
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 18282922
• MDR Text Key: 330045341
• Report Number: MW5148943
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A300316A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White