MAUDE Adverse Event Report: C.R. BARD, INC. FOLEY CATHETER SYSTEM; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Lot Number 071614

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Separation (1562); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2021

Event Type  malfunction  

Event Description

Bedside rn discovered hole in foley bag at bottom that was leaking urine onto floor of patient's room - clear defect in bag where it had not fully separated during manufacturing.Appears that as urine filled bag, it started to separate bag at that point.That did not happen during manufacturing and this tore hole in the bag.Foley was placed in or yesterday for heart surgery; only bag changed out.Expected that foley will be d/c'd later today or early tomorrow as part of normal post-op heart surgery trajectory.This is the 6th known patient with a leaking bard foley bag; catheter is a 16fr temp probe foley with urimeter system.

• Brand Name: FOLEY CATHETER SYSTEM
• Type of Device: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12273740
• MDR Text Key: 264951700
• Report Number: 12273740
• Device Sequence Number: 1
• Product Code: KNX
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 071614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 80