MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367861
Medical Device Problem Codes	Material Deformation (2976); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Report 2 of 2.It was reported while using bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, there was one (1) tube with a plastic protrusion inside the tube.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
There were multiple medical device types: d2b: medical device type: jka.There were multiple 510k numbers.G4: 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
The following fields were updated due to additional information: h.1.Imdrf annex a grid (1): a0411 - material protrusion / extrusion (2979).Investigation summary: bd received 3 photos for investigation.The photos were reviewed showing a damaged tube with a protrusion inside.Nowhere on the production line is there anything introduced to the inside of the tube that would cause this type of defect.The exact cause for the customer¿s failure mode could not be determined with the investigation completed.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.This complaint has been confirmed for: damaged.This complaint has not been confirmed for a molding defect.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
Report 2 of 2.It was reported while using bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, there was one (1) tube with a plastic protrusion inside the tube.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
• 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): 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: 24612393
• Report Number: 1917413-2026-00178
• Device Sequence Number: 9834594
• Product Code: GIM
• UDI-Device Identifier: 30382903678618
• UDI-Public: (01)30382903678618(11)250716(17)261130(10)5197575
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/23/2026

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: 367861
• Device Lot Number: 5197575
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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