MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368884
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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
Report 2 of 2, it was reported while using bd vacutainer® lh (lithium heparin) 68 i.U.Plus blood collection tubes, the stopper of one tube popped off resulting in sample leakage and exposure to blood on the manager's hands and the bench.The level of ppe worn is unknown.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes h.3 device eval by manufacturer? yes d9: returned to manufacturer on: 28-jul-2025 investigation summary bd received 3 customer samples for investigation.The 3 customer samples along with 20 retained samples were subjected to a draw-test for low or no draw and all tubes drew within specification.Additionally, the 3 customer samples and 20 retained samples were evaluated by functional testing for stopper creepout and stopper pop off and no issues were observed as all samples met specifications.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 stopper creepout and stopper pop 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
Report 2 of 2 it was reported while using bd vacutainer® lh (lithium heparin) 68 i.U.Plus blood collection tubes, the stopper of one tube popped off resulting in sample leakage and exposure to blood on the manager's hands and the bench.The level of ppe worn is unknown.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22513091
• Report Number: 9617032-2025-01250
• Device Sequence Number: 15637465
• Product Code: JKA
• UDI-Device Identifier: 30382903688846
• UDI-Public: (01)30382903688846(17)260531(10)5029152
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 05/31/2026
• Device Catalogue Number: 368884
• Device Lot Number: 5029152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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