MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) VACUTAINER; BLOOD COLLECTION SET, INVASIVE

Catalog Number	368652
Medical Device Problem Code	Leak/Splash (1354)
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
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® safety-lok¿ blood collection set pre-attached holder there was unspecified sample leakage from 3 devices.Recollection was required.No additional adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd did not receive any samples or photos for investigation.A total of 30 retained samples were visually inspected and underwent functional tests for leaks, and all samples passed testing.All process and final inspections comply with specification requirements.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 of leakage.Based on a review of batch records and investigation results, no root cause from manufacturing was identified as a contributor.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 when using the bd vacutainer® safety-lok¿ blood collection set pre-attached holder there was unspecified sample leakage from 3 devices.Recollection was required.No additional adverse impact was reported regarding the patient or user.

• Brand Name: VACUTAINER
• Common Device Name: BLOOD COLLECTION SET, INVASIVE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22646750
• Report Number: 1024879-2025-01053
• Device Sequence Number: 18333533
• Product Code: JKA
• UDI-Device Identifier: 00382903686520
• UDI-Public: (01)00382903686520(11)250415(17)270228(10)5083132
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K980414
• 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): 12/08/2025

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 Catalogue Number: 368652
• Device Lot Number: 5083132
• 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: 12/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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