MAUDE Adverse Event Report: E K INDUSTRIES, INC. FORMALIN CONTAINER 60ML; FORMALIN, NEUTRAL BUFFERED

Model Number 24499-100X60ML

Patient Problem Insufficient Information (4580)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

Formalin container found with broken lid.Almost entire plastic circle in center of lid broken.Manufacturer response for 60ml container, 60ml container (per site reporter).Mfg acknowledged they would look into it and fix, failed to fix.We are converting to a medline product due to ongoing issues since [redacted date].

• Brand Name: FORMALIN CONTAINER 60ML
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): E K INDUSTRIES, INC.; 1403 herkimer st; joliet IL 60432
• MDR Report Key: 18169633
• MDR Text Key: 328533486
• Report Number: 18169633
• Device Sequence Number: 1
• Product Code: IFP
• 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: 09/26/2023

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: 24499-100X60ML
• Device Lot Number: 2215441
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1