MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Catalog Number	367899
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	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes, an unspecified number of tubes were used after the expiration date.There was no health impact or consequences reported.
Additional Manufacturer Narrative
D2a.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.D2b.Common device name: tubes, vials, systems, serum separators, blood collection.There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k213670; k231373.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd did not receive any samples or photos for investigation.The product expired on 30 nov 2025.Since the product is expired, no retained samples could be inspected.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has been confirmed for the indicated failure mode: expired.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported while using bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes, an unspecified number of tubes were used after the expiration date.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24203743
• Report Number: 1917413-2026-00021
• Device Sequence Number: 5484076
• Product Code: GIM
• UDI-Device Identifier: 30382903678991
• UDI-Public: (01)30382903678991(11)240617(17)250930(10)4169570
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: BK230980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 09/30/2025
• Device Catalogue Number: 367899
• Device Lot Number: 4169570
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown