MAUDE Adverse Event Report: HARDY DIAGNOSTICS VIRAL TRANSPORT MEDIUM, 3 ML; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Lot Number 461289P

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/11/2020

Event Type  malfunction  

Event Description

Contaminated viral transport media (vtm).Hardy diagnostics viral transport medium, 3 ml ref: (b)(4), lot #461289p, exp 11-11-2020.Manufacturer claims: room temperature storage before inoculation has been validated for up to 30 days.The product was stored at room temperature for less than 14 days and two vials appeared to be contaminated with fungus; 1 vial had a fungus ball floating in the liquid.The other vial's lid had a black film on the inside of the lid.Both vials had turned color from reddish to yellow which indicates microorganism contamination.

• Brand Name: VIRAL TRANSPORT MEDIUM, 3 ML
• Type of Device: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): HARDY DIAGNOSTICS
• MDR Report Key: 10605718
• MDR Text Key: 209455451
• Report Number: MW5096938
• Device Sequence Number: 2
• Product Code: JSM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 461289P
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1