MAUDE Adverse Event Report: Q.I. MEDICAL, INC. ENVIROTEST; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number ET1000

Device Problem Microbial Contamination of Device (2303)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Event Description

Our home infusion company uses qi medical's envirotest as part of our environmental monitoring program in our clean room.One of our technicians took a container out of the box to use today and noticed there was growth on both sides of the paddle.The plastic container with the red top that the paddle is in was, and still is, completely sealed.The qi medical item number is et1000, the lot number is 1897520, and the expiration date is 8/28/21.This container/paddle is the only one in the box that has visible growth.We have already used paddles with this lot number in our past monthly environmental monitoring.Every month from 11/25/2020 until now, we have used envirotest paddles with the lot number 1897520.No growth was observed on those paddles.We still have 20 containers/paddles with the lot number 1897520 left in stock.I called qi medical this morning to report this.I left a message for someone to call me back.I currently have the affected product in our pharmacy.I will be sending it to qi medical if they request it when they follow up.If they do not, i will have it tested at our local lab.I also have pictures available of the affected product.Fda safety report id # (b)(4).

• Brand Name: ENVIROTEST
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): Q.I. MEDICAL, INC.; grass valley CA 95945
• MDR Report Key: 11602746
• MDR Text Key: 243642123
• Report Number: MW5100482
• Device Sequence Number: 1
• Product Code: JSG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/30/2021

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 Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: ET1000
• Device Lot Number: 1897520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1