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

Catalog Number	367391
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D2a.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: jka.D2b.Common device name: tubes, vials, systems, serum separators, blood collection.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 while using bd vacutainer® ultratouch¿ push button blood collection set, an unspecified number of devices exhibited poor sleeve function leading to blood leakage and including excessive resistance when inserting the tube.There was no health impact or consequences reported.
Event or Problem Description
It was reported while using bd vacutainer® ultratouch¿ push button blood collection set, an unspecified number of devices exhibited poor sleeve function leading to blood leakage and including excessive resistance when inserting the tube.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received 2 photos for investigation from the customer, which show a device with blood leakage in the holder and a sleeve that is not properly recovered over the np cannula.Additionally, 30 retained samples were subjected to functional tests to assess device functionality.Out of these, two samples failed testing, as sleeve leakage was observed due to poor sleeve recovery.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 function.This complaint has not been confirmed for the indicated failure mode: tube push off.Bd has initiated corrective and preventive action to address the reported 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: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• 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: 24070202
• Report Number: 1024879-2025-02442
• Device Sequence Number: 9206106
• Product Code: FPA
• UDI-Device Identifier: 00382903673919
• UDI-Public: (01)00382903673919(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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 12/17/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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