MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® PLUS CITRATE TUBE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	363048
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	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Report 1 of 3: it was reported while using bd vacutainer® plus citrate tube, 1 patient sample exhibited erroneous high d-dimer results.The patient was sent to the emergency room and a new sample was collected which was lower.There was no other health impact or consequences reported.
Event or Problem Description
Report 1 of 3: it was reported while using bd vacutainer® plus citrate tube, 1 patient sample exhibited erroneous high d-dimer results.The patient was sent to the emergency room and a new sample was collected which was lower.There was no other health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples or photos for investigation.Therefore, a total of 100 retained samples were visually inspected, and no additive abnormalities were found.Further clinical testing could not be conducted as the tubes were expired at the time of review and the other batch numbers were unknown.Clinical evaluation cannot be conducted on expired tubes.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 not been confirmed for the lot 5121160, for the indicated failure mode: erroneous results (d-dimer).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.

• Brand Name: BD VACUTAINER® PLUS CITRATE TUBE
• 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 AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23708148
• Report Number: 9617032-2025-02124
• Device Sequence Number: 10691250
• Product Code: JKA
• UDI-Device Identifier: 30382903630487
• UDI-Public: (01)30382903630487(11)250501(17)260131(10)5121160
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 01/31/2026
• Device Catalogue Number: 363048
• Device Lot Number: 5121160
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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