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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using two (2) bd vacutainer® ultratouch¿ push button blood collection set, the non-patient sleeve did not cover the needle after removing the tube, causing blood to leak into the holder and on the patient's arm.There was no health impact or consequence reported.
Additional Manufacturer Narrative
E1: initial reporter phone #:(b)(6).D.2b medical device type: one additional code applies; jka.E1: initial reporter facility name: (b)(6).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 that while using two (2) bd vacutainer® ultratouch¿ push button blood collection set, the non-patient sleeve did not cover the needle after removing the tube, causing blood to leak into the holder and on the patient's arm.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation, which shows blood leakage in the sample of the device.However, the photo does not show the sleeve or evidence of leakage in the holder.Additionally, 30 retained samples were subjected to functional tests.Out of these, two samples failed testing due to sleeve leakage observed from poor sleeve recovery.All samples passed the functional test for retraction lockout, 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 modes: leakage and sleeve side piercing.Based on a review of batch records, no root cause from manufacturing was identified as a contributor for leakage after use.For sleeve function, corrective and preventive action has been opened to address the 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.

• 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: 21411484
• Report Number: 1024879-2025-00161
• Device Sequence Number: 18221967
• 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): 03/14/2025

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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/10/2025
• 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