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 Codes	Off-Label Use (1494); Device Ingredient or Reagent Problem (2910); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd microtainer® tubes with k2e (k2edta), an unspecified number of tubes underwent hemolysis, and the plasma did not separate properly.Upon inspection, after use, the customer noticed that the tubes were expired.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received two photos for investigation.The photos were reviewed and the indicated failure mode for hemolysis was observed.Assessment of the bd retention samples for lot 2290067 could not be performed, as the lot reached its expiry date on 31 mar 2024 and the defined storage duration had been exceeded.Complaints for sample quality are under statistical control for the month of november 2025.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 modes: hemolysis and expired.This complaint is unable to be confirmed for the indicated failure mode: poor barrier separation.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.
Additional Manufacturer Narrative
B3.Date of event is unknown.The date received by manufacturer has been used for this field.E1.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), an unspecified number of tubes underwent hemolysis, and the plasma did not separate properly.Upon inspection, after use, the customer noticed that the tubes were expired.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: 23831309
• Report Number: 2618282-2025-00149
• Device Sequence Number: 20107207
• Product Code: JKA
• UDI-Device Identifier: 30382903659747
• UDI-Public: (01)30382903659747(17)240331(10)2290067
• 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): 01/29/2026

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 365974
• Device Lot Number: 2290067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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