MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® SODIUM FLUORIDE: 3 MG NA2 EDTA: 6 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367587
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
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
It was reported that when using bd vacutainer® sodium fluoride: 3 mg na2 edta: 6 mg blood collection tubes, there was inadequate blood draw volume in 1 device.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received two photos for investigation.The photos were reviewed and the indicated failure mode for underfill was observed.A total of 100 retained samples were visually inspected, and no visible defects were found.Furthermore, 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 lot, all product specifications and requirements for lot release were met.This complaint has been confirmed for the indicated failure mode: underfill.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 that when using bd vacutainer® sodium fluoride: 3 mg na2 edta: 6 mg blood collection tubes, there was inadequate blood draw volume in 1 device.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9.Returned to manufacturer: yes, h.3 device eval by manufacturer? yes, d9.Device available for eval?: 06-feb-2026.E1: (b)(6).Investigation summary: bd received 10 samples and 2 photos for investigation.The visually evaluated photos showed the customer¿s indicated failure mode.The 10 samples were inspected with no issues being identified.A draw test was performed on 10 sample tubes.All tubes were within specification limits.Additionally, a total of 100 retention samples were visually inspected, with no visible defects observed.Furthermore, 10 retention samples underwent functional testing, and all tubes were within specification limits.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: underfill.No definitive root cause could be established for the reported defect.Based on the low defect rate for the batch in question, no actions are planned at this time.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
It was reported that when using bd vacutainer® sodium fluoride: 3 mg na2 edta: 6 mg blood collection tubes, there was inadequate blood draw volume in 1 device.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE: 3 MG NA2 EDTA: 6 MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 23843894
• Report Number: 1917413-2025-01696
• Device Sequence Number: 18631654
• Product Code: JKA
• UDI-Device Identifier: 30382903675877
• UDI-Public: (01)30382903675877(17)260228(10)4288048
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 02/23/2026

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 367587
• Device Lot Number: 4288048
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 02/23/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/15/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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