MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® SODIUM FLUORIDE: 3 MG NA2 EDTA: 6 MG BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367587
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Report 1 of 2: it was reported while using bd vacutainer® sodium fluoride: 3 mg na2 edta: 6 mg blood collection tubes, an unspecified number of tubes underfilled leading to erroneous results.No adverse impact was reported regarding the patient or user.
Event or Problem Description
Report 1 of 2.It was reported while using bd vacutainer® sodium fluoride: 3 mg na2 edta: 6 mg blood collection tubes, an unspecified number of tubes underfilled leading to erroneous results.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received 2 photos for investigation from catalog 367587, lot numbers 5048280 and 5015971.The photos were visually evaluated showing the indicated failure mode of underfill; however, the indicated failure mode of erroneous results could not be confirmed.Additionally, 100 retained samples from the production lot were inspected, with 0 visible defects observed.Functional tests were performed on 10 retained samples, and all tubes were within specification limits.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 the lots 5015971 and 5048280 for the indicated failure mode: underfill.This complaint has not been confirmed for the lots 5015971 and 5048280 for the indicated failure mode: erroneous results (accuracy).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.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE: 3 MG NA2 EDTA: 6 MG 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: 24506914
• Report Number: 1917413-2026-00158
• Device Sequence Number: 13389315
• Product Code: JKA
• UDI-Device Identifier: 30382903675877
• UDI-Public: (01)30382903675877(17)260630(10)5048280
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K231237
• 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): 03/11/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 367587
• Device Lot Number: 5048280
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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