MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg Blood Collection Tubes; Tubes, vials, systems, serum separators, blood collection

Catalog Number	368381
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Report 19 of 20\ it was reported that after using bd vacutainer® trace element k2 edta (k2e) 10.8mg blood collection tubes, an unspecified number of tubes from one patient exhibited elevated molybdenum results during in-house icpms testing.The patient was contacted for sample recollection.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information:\ h.3 device eval by manufacturer? yes\ \ investigation summary:\ an investigation was conducted in response to a customer inquiry regarding molybdenum in bd vacutainer® edta trace element tubes.The investigation included a review of customer information, complaint history, device history records, and risk management documentation.Customer samples were available for evaluation.The investigation did not identify a manufacturing, design, or lot-specific nonconformance associated with the reported concern.Visual inspection of 100 retention samples along with the 99 returned samples identified no abnormalities, and review of the device history record confirmed that all manufacturing and inspection activities were performed in accordance with established requirements.\ \ the investigation identified elevated molybdenum levels in certain lots of edta trace element tubes.Icp testing confirmed variability in molybdenum levels between lots; however, no manufacturing process or product design changes were identified that could account for the observed results.While the investigation identified potential sources of variability within the material supply chain, the available evidence was insufficient to establish a definitive root cause.Molybdenum (mo) is not a validated analyte for this product and is not included within the product's intended use, product claims, or release specifications.Accordingly, molybdenum is not routinely tested as part of product release.\ \ enhanced manufacturing process controls have been implemented to monitor trace element variability in raw material inputs and support continued consistency of product performance.\ \ based on the available information, no evidence was identified to support a manufacturing, design, or lot-related nonconformance associated with the subject lot.Therefore, this complaint was not confirmed for the reported failure mode of erroneous results, and no corrective action was warranted.Complaints related to this issue will continue to be monitored and trended in accordance with established complaint handling procedures.

• Brand Name: BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg 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 ; +1(201)847-5186
• MDR Report Key: 50735910
• Report Number: 1917413-2026-00846
• Device Sequence Number: 18807025
• Product Code: JKA
• UDI-Device Identifier: 30382903683810
• UDI-Public: (01)30382903683810(11)260216(17)270228(10)6047682
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K213953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 368381
• Device Lot Number: 6047682
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2026
• 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