MAUDE Adverse Event Report: CITOTEST SCIENTIFIC / CITOTEST LABWARE MANUFACTURING CO., LTD. CITOSWAB VTM; TRANSPORT MEDIUM, NOTIFIED PER THE VTM GUIDANCE

Model Number VTM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

The citoswab vtm container broke.The lid split into two pieces the threaded part came away from the top and the vtm could have leaked out.This thankfully broke while opening the container in the lab so that sample was able to be used.Fda safety report id# (b)(4).

• Brand Name: CITOSWAB VTM
• Type of Device: TRANSPORT MEDIUM, NOTIFIED PER THE VTM GUIDANCE
• Manufacturer (Section D): CITOTEST SCIENTIFIC / CITOTEST LABWARE MANUFACTURING CO., LTD.
• MDR Report Key: 11684982
• MDR Text Key: 246262336
• Report Number: MW5100834
• Device Sequence Number: 1
• Product Code: QMC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2021
• Device Model Number: VTM
• Device Lot Number: 092044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 35 YR