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

Catalog Number	367365
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d.2.A medical device type: jka.D.2.B common device name: tubes, vials, systems, serum separators, blood collection.Bd received a video for investigation.Evaluation of the provided video demonstrated damaged tubing resulting in leakage.A review of the device history record (dhr) indicated that a quality notification had previously been initiated for this issue.However, the lot met all in-process and final inspection requirements and was released in accordance with applicable specifications.Based on the available evidence, the complaint is confirmed for the reported failure mode of damaged tubing that resulted in blood leakage.Bd has initiated corrective and preventive action to address the reported issue.Complaints received for this device and reported conditions will continue to be tracked and trended.Our business team regularly reviews the collected data for monitoring current trends and identification of emerging trends.
Event or Problem Description
It was reported while using bd vacutainer® ultratouch¿ push button blood collection set, sample leakage occurred between the luer adapter and tubing junction.This occurred with 6 devices resulting in recollection.No adverse impact was reported regarding the patient or user.

• 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 AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 25453100
• Report Number: 9617032-2026-01014
• Device Sequence Number: 10347324
• Product Code: FPA
• UDI-Device Identifier: 00382903673650
• UDI-Public: (01)00382903673650(11)250827(17)270831(10)5239612
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 05/14/2026

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 Catalogue Number: 367365
• Device Lot Number: 5239612
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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