MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) BD Vacutainer® UltraTouch¿ Push Button Blood Collection Set; Set, administration, intravascular

Catalog Number	367364
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Report 7 of 8.It was reported while using bd vacutainer® ultratouch¿ push button blood collection set, blood leaked from a crack in the hub of one (1) device.A new device was selected and the patient sample was recollected.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9: device available for evaluation: yes h.3: device eval by manufacturer? yes d.9: returned to manufacturer on: 28-sep-2026.Investigation summary: bd received 150 samples for investigation.Out of these, 20 samples were randomly selected and visually inspected; none of the samples indicated a split female luer adapter.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.While bd was unable to confirm this complaint for the indicated failure mode damaged, bd has initiated further root cause investigation relating to the issue of damaged/broken female luer through corrective and preventive actions.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for 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 AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; +1(201)847-5186
• MDR Report Key: 50922132
• Report Number: 9617032-2026-01721
• Device Sequence Number: 14904031
• Product Code: FPA
• UDI-Device Identifier: 30382903673644
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 367364
• Device Lot Number: 6091475
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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