MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES; EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT

Catalog Number	366643
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b.Medical device type: there were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k213670, k231373.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported before using the bd vacutainer® k2 edta (k2e) plus blood collection tubes there was discolored additive in an unspecified number of devices.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
Investigation summary - the following fields have been updated with additional information: d10.Device available for eval- yes d10.Returned to manufacturer on: 28-jan-2025 h3.Device eval by manufacturer- yes bd received five (5) samples and three (3) photos for investigation.The evaluation of the photos shows that the tube does not have an additive abnormality; instead, the brown color on the tube is identified as a burn mark, which is a tube molding defect.The investigation of the five (5) returned samples concluded that the suspected additive abnormality was indeed a burn mark.Additionally, 100 retained samples were visually inspected, and no tube defects were identified.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: molding defect.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 before using the bd vacutainer® k2 edta (k2e) plus blood collection tubes there was discolored additive in an unspecified number of devices.There were no health consequences or impacts reported.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
• Common Device Name: EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21206864
• Report Number: 9617032-2024-02178
• Device Sequence Number: 19819312
• Product Code: GIM
• UDI-Device Identifier: 30382903666431
• UDI-Public: (01)30382903666431(11)240524(17)250531(10)4145570
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 05/31/2025
• Device Catalogue Number: 366643
• Device Lot Number: 4145570
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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