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

Model Number 4499100X60ML

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Eki 10% formalin fixative 60ml, lot# 2236109, exp# [redacted date] unused bottle had things in the formalin bottle.Manufacturer response for formalin container, formalin container (per site reporter).Ongoing issue at the time.

• 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: 17236722
• MDR Text Key: 318216384
• Report Number: 17236722
• 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: 06/21/2023

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: 4499100X60ML
• Device Lot Number: 2236109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1