MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367884
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
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
It was reported while using bd vacutainer® lithium heparinn (lh) 75 usp units blood collection tubes, there was tube push off leading to underfill with thirty (30) tubes.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received two photos for investigation.The photos depict a tube being filled and a shelf pack of tubes; however, they do not display the customer's indicated failure mode.A total of 100 retained samples were visually inspected with no issues identified.Additionally, 10 retained samples from the production lot were inspected and no visible defects were found.A functional test was performed on these 10 retained samples, and all tubes were found to be 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 not been confirmed for the indicated failure mode: tube push off.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 while using bd vacutainer® lithium heparinn (lh) 75 usp units blood collection tubes, there was tube push off leading to underfill with thirty (30) tubes.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 22640138
• Report Number: 1917413-2025-00999
• Device Sequence Number: 9538428
• Product Code: JKA
• UDI-Device Identifier: 30382903678847
• UDI-Public: (01)30382903678847(17)250831(10)4102601
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K901449
• 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): 10/23/2025

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: 08/31/2025
• Device Catalogue Number: 367884
• Device Lot Number: 4102601
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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