MAUDE Adverse Event Report: COVIDIEN DOVER SILVER COATED 100% SILICONE URINE METER FOLEY TRAY; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 7006ICLL

Patient Problem Insufficient Information (4580)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

All lots have been pulled.Covidien dover silver coated 100% silicone urine meter foley tray has leaking drainage bags x3.Ref# 7006icll, lot # 2223120264.Tracking issues with components as well as kits.

• Brand Name: DOVER SILVER COATED 100% SILICONE URINE METER FOLEY TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 18463605
• MDR Text Key: 332296010
• Report Number: 18463605
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 7006ICLL
• Device Lot Number: 2223120264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1