MAUDE Adverse Event Report: E K INDUSTRIES, INC. PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ.); FORMALIN, NEUTRAL BUFFERED

Model Number 24499-100X120ML

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

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

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Unpacking new formalin box and noticed empty formalin bottle, which was cracked but box was dry bottom.Lot number 2207503.Expiry: year 2024.Brand eki 120ml bottle.

• Brand Name: PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ.)
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): E K INDUSTRIES, INC.; 1403 herkimer st; joliet IL 60432
• MDR Report Key: 15191758
• MDR Text Key: 297520229
• Report Number: 15191758
• 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: 07/05/2022

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: 24499-100X120ML
• Device Lot Number: 2207503
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1