MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG; EVACUATED BLOOD COLLECTION TUBE IVD

Catalog Number	367921
Medical Device Problem Codes	Short Fill (1575); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).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 when using the bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg there was low sample draw volume and sample hemolysis in an unspecified number of devices.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary : bd had not received any samples for investigation.A total of 100 retained samples were visually inspected, with the hemogard closure assembly correctly assembled and placed on the tubes.A functional test was performed on 10 retained samples.All tubes were within specification limits with no issues identified.Complaints for sample quality are under statistical control for the month of july 2025.At this time, further testing is not indicated.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 hemolysis.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.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported when using the bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg there was low sample draw volume and sample hemolysis in an unspecified number of devices.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
• Common Device Name: EVACUATED BLOOD COLLECTION TUBE IVD
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22644482
• Report Number: 1917413-2025-01003
• Device Sequence Number: 8678094
• Product Code: JKA
• UDI-Device Identifier: 30382903679219
• UDI-Public: (01)30382903679219(10)4318890
• 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): 10/01/2025

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: 367921
• Device Lot Number: 4318890
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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