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

Lot Number 092044

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

Citoswab tube broke.Discovered in lab when tech was preparing to do test.No vtm had spilled out.Fda safety report id# (b)(4).

• Brand Name: CITOSWAB
• Type of Device: TRANSPORT MEDIUM, NOTIFIED PER THE VTM GUIDANCE
• Manufacturer (Section D): CITOTEST SCIENTIFIC / CITOTEST LABWARE MANUFACTURING CO., LTD.
• MDR Report Key: 11684995
• MDR Text Key: 246259620
• Report Number: MW5100835
• 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 Lot Number: 092044
• Was Device Available for Evaluation?: No
• 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: 39 YR