MAUDE Adverse Event Report: E K INDUSTRIES, INC. FIXATIVE, FORMALIN; FORMALDEHYDE (FORMALIN, FORMOL)

Model Number 24499-100X60ML

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

Black speck noted floating in specimen container.Upon closer inspection appears to be a dead bug noted in 10% formalin fixative specimen container.Manufacturer response for formalin specimen container, fixative, formalin 10pct, 60ml prefill (per site reporter): (b)(4) distributor is facilitating the communication.Clinical site filled out the product complaint form.Awaiting instructions to return.Pictures sent to the representative and attached to this report.

• Brand Name: FIXATIVE, FORMALIN
• Type of Device: FORMALDEHYDE (FORMALIN, FORMOL)
• Manufacturer (Section D): E K INDUSTRIES, INC.; 1403 herkimer st; joliet IL 60432
• MDR Report Key: 12951899
• MDR Text Key: 281847780
• Report Number: 12951899
• Device Sequence Number: 1
• Product Code: IGG
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 24499-100X60ML
• Device Lot Number: 2127911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1