MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) VACUTAINER; EVACUATED BLOOD COLLECTION TUBE IVD

Catalog Number	367921
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
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 when using the bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg one tube was cracked and specimen leaked on one device.There was also low sample draw volume on the same device.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported when using the bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg one tube was cracked and specimen leaked on one device.There was also low sample draw volume on the same device.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd had not received any samples or photos for investigation.Therefore, 100 retained samples were visually inspected and found to have the hemogard closure assembly correctly assembled and placed on the tubes with no issues identified.Additionally, a functional test was performed 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: cracked product/component and 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.

• Brand Name: VACUTAINER
• 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: 22634492
• Report Number: 1917413-2025-00985
• Device Sequence Number: 7994942
• Product Code: JKA
• UDI-Device Identifier: 30382903679219
• UDI-Public: (01)30382903679219(17)251231(10)4257304
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 12/31/2025
• Device Catalogue Number: 367921
• Device Lot Number: 4257304
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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