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

Catalog Number	367391
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using one (1) bd vacutainer® ultratouch¿ push button blood collection set, sleeve leakage occurred.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
D2b: additional medical device type: fpa.Investigation summary: bd received 2 photos for investigation.One of the customer photos shows a device with blood leakage in the holder and a sleeve that is not properly recovered over the np cannula.Thirty (30) retained samples underwent functional tests for sleeve function testing and 2 of the samples failed testing as there was sleeve leakage observed due to poor sleeve recovery.Additionally, 30 retained samples underwent functional testing for retraction lockout testing.All samples passed testing as they were able to be activated properly with no evidence of defects or leakage 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.Bd has initiated further root cause investigation relating to the issue of sleeve leakage through corrective and preventive actions.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: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE; 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: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23522765
• Report Number: 1024879-2025-01769
• Device Sequence Number: 21356615
• Product Code: JKA
• UDI-Device Identifier: 00382903673919
• UDI-Public: (01)00382903673919(11)241015(17)260930(10)4289781
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 10/14/2025
• Initial Report FDA Received Date: 11/11/2025
• 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