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

Model Number	TVT-03
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The line of the manufacturers' address '11 little balmer' was missing from the labels, tvt-03-1 foil pouch rev 5, 2023-08.Tvt-03-2 foil pouch rev 6, 2023-08.Tf-01-10.

• 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: 19804846
• Report Number: 3003315146-2024-23001
• Device Sequence Number: 15334633
• 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
• Device Model Number: TVT-03
• Device Catalogue Number: TVT-03-1, TVT-03-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 07/23/2024
• Is the Device Labeled for Single Use? (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