MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	367391
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2b medical device type: one additional code applies; jka.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 that while using eleven (11) bd vacutainer® ultratouch¿ push button blood collection set, the needles broke, and the needles got stuck while extracting the tube, causing blood to spill out.No patient or user impact reported.
Additional Manufacturer Narrative
Investigation summary: bd received five photos for investigation.The analysis of the photos shows a device with blood leakage in the holder and on surrounding surfaces; however, the sleeve is not visible and cannot be evaluated for side piercing or recovery.Additionally, there is no evidence of device breakage.A total of 30 retained samples underwent functional tests.During these tests, two samples failed due to sleeve leakage observed, attributed to poor sleeve recovery, but there was no evidence of needle breakage.Furthermore, all 30 retained samples passed another set of functional tests, demonstrating proper activation with no defects, breakage, or leaking observed.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 been confirmed for the indicated failure mode: sleeve leakage and unconfirmed for the indicated failure mode of breaks off.No root cause from manufacturing was identified as a contributor for the breaks off during use.However, corrective and preventive action has been opened to address the sleeve leakage issue.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 that while using eleven (11) bd vacutainer® ultratouch¿ push button blood collection set, the needles broke, and the needles got stuck while extracting the tube, causing blood to spill out.No patient or user impact reported.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 21697093
• Report Number: 1024879-2025-00368
• Device Sequence Number: 12928701
• Product Code: FPA
• UDI-Device Identifier: 30382903673910
• UDI-Public: (01)30382903673910(11)241015(17)260930(10)4289781
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K212724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: 09/30/2026
• Device Catalogue Number: 367391
• Device Lot Number: 4289781
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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