MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; SEE H.11

Catalog Number	367391
Medical Device Problem Code	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
Investigation summary - bd had not received any samples for investigation.A total of 30 retained samples were subjected to functional tests.Two of the retained samples failed the functional test due to sleeve leakage observed from poor sleeve recovery.Additionally, all 30 retained samples passed another set of functional tests, showing proper activation with no 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.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.
Event or Problem Description
It was reported that while using the bd vacutainer® ultratouch¿ push button blood collection set that at the moment of connecting the tubes to the vacuum it is difficult to introduce the needle, and the blood begins to pass to the holder causing spills.No patient impact reported.
Event or Problem Description
It was reported that while using the bd vacutainer® ultratouch¿ push button blood collection set that at the moment of connecting the tubes to the vacuum it is difficult to introduce the needle, and the blood begins to pass to the holder causing spills.No patient impact reported.
Additional Manufacturer Narrative
The information for the additional medical device type is as follows: d.2b.Medical device type: jka d.2a.Common device name: blood specimen collection device; intravascular administration set 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 the bd vacutainer® ultratouch¿ push button blood collection set that at the moment of connecting the tubes to the vacuum it is difficult to introduce the needle, and the blood begins to pass to the holder causing spills.This occurred 6 times.No patient impact reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.5: "it was reported that while using the bd vacutainer® ultratouch¿ push button blood collection set that at the moment of connecting the tubes to the vacuum it is difficult to introduce the needle, and the blood begins to pass to the holder causing spills.This occurred 6 times.No patient impact reported." investigation summary bd had not received any samples for investigation.A total of 30 retained samples were subjected to functional tests.Two of the retained samples failed the functional test due to sleeve leakage observed from poor sleeve recovery.Additionally, all 30 retained samples passed another set of functional tests, showing proper activation with no 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.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: SEE H.11
• 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: 21657383
• Report Number: 1024879-2025-00344
• Device Sequence Number: 12646264
• 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,Followup
• Report Date (Section B): 05/02/2025

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: 04/04/2025; 05/02/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/30/2025
• 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