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

Model Number 24499-100X60ML

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

Specimen jar in the procedure room was noted to have a black particle floating in it.The jar was removed from the stock and apsm notified.

• Brand Name: FORMALIN
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): E K INDUSTRIES, INC.; 1403 herkimer st; joliet IL 60432
• MDR Report Key: 17660474
• MDR Text Key: 322389115
• Report Number: 17660474
• 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: 08/11/2023

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: 2236109
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1