MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD MICROTAINER® TUBES WITH K2E (K2EDTA); TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	365974
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter facility name: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd microtainer® tubes with k2e (k2edta), clotting is seen in an unspecified number of tubes.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9.Returned to manufacturer: yes.H.3 device eval by manufacturer? yes.D9.Device available for eval? 02-apr-2026.Investigation summary: bd received 3 samples for investigation.The 3 samples along with 50 retention samples were evaluated for visual presence of additive and foreign matter with acceptable results.Additionally, the 3 samples and 14 retention samples were tested for additive concentration.One of the 3 returned samples and one of the 14 retained sample failed.Complaints for sample quality are under statistical control for the month of february 2026.At this time, further testing is not indicated.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode clotting.This complaint is unable to be confirmed for the indicated failure mode hemolysis.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported while using bd microtainer® tubes with k2e (k2edta), clotting is seen in an unspecified number of tubes.No adverse impact was reported regarding the patient or user.

• Brand Name: BD MICROTAINER® TUBES WITH K2E (K2EDTA)
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24702396
• Report Number: 2618282-2026-00046
• Device Sequence Number: 13379032
• Product Code: JKA
• UDI-Device Identifier: 30382903659747
• UDI-Public: (01)30382903659747(17)261130(10)5167297
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K940905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: Other
• Device Catalogue Number: 365974
• Device Lot Number: 5167297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown