MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367921
Medical Device Problem Codes	Backflow (1064); Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
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 during blood collection using bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg, 1 tube was underfilled and blood flow stopped.Sample back-flowed in acquisition device back to patient.The tube was replaced.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 all components were correctly assembled.Additionally, functional tests were conducted on 10 retained samples, and all tubes were within specification limits with no issues 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 not been confirmed for the indicated failure modes: underfill and harm-other.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 during blood collection using bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg, 1 tube was underfilled and blood flow stopped.Sample back-flowed in acquisition device back to patient.The tube was replaced.There was no other health impact or consequences reported.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• 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: 23350414
• Report Number: 1917413-2025-01446
• Device Sequence Number: 20822580
• Product Code: JKA
• UDI-Device Identifier: 30382903679219
• UDI-Public: (01)30382903679219(17)250930(10)4166519
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/27/2026

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: 09/30/2025
• Device Catalogue Number: 367921
• Device Lot Number: 4166519
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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