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

Model Number 24499-100X60ML

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

6 formalin jars found in drawer with cracked lids all with lot# 2215441 exp [redacted date].Additional formalin container was found to have large crack in lid.Lot# 2229926 exp [redacted date].Manufacturer response for formalin container, (brand not provided) (per site reporter) notified them in january, escalated it to them or correction.Already converting to a different brand due to ongoing issues and concerns.

• Brand Name: FORMALIN CONTAINER
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): E K INDUSTRIES, INC.; 1403 herkimer st; joliet IL 60432
• MDR Report Key: 17419638
• MDR Text Key: 319990651
• Report Number: 17419638
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/05/2023

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, 2229926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1