MAUDE Adverse Event Report: CALTAG MEDSYSTEMS LTD CYTOMARK; TRANSFIX/EDTA VACUUM BLOOD COLLECTION TUBES

Model Number	TVT-03
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concluded that there was no defect with the device.The clotting was due to inadequate mixing of the tubes at the time of phlebotomy (failure to follow the ifu).
Event or Problem Description
Issue of blood clotting in tubes.

• Brand Name: CYTOMARK
• Common Device Name: TRANSFIX/EDTA VACUUM BLOOD COLLECTION TUBES
• Manufacturer (Section D): CALTAG MEDSYSTEMS LTD; 11 little balmer; buckingham, bucks MK18 1TF; UK MK18 1TF
• Manufacturer Contact: nicki kaenzig ; 11 little balmer; buckingham, bucks MK18 -1TF ; UK MK18 1TF
• MDR Report Key: 19805734
• Report Number: 3003315146-2024-24002
• Device Sequence Number: 12859248
• Product Code: GIM
• UDI-Device Identifier: 05060531711603
• UDI-Public: 05060531711603
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: TVT-03
• Device Catalogue Number: TVT-03-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown