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

Catalog Number	367363
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types: d2b: medical device type: jka.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 prior to using bd vacutainer® ultratouch¿ push button blood collection set, there was one (1) device that the spring popped out when the needle sheath was removed.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported prior to using bd vacutainer® ultratouch¿ push button blood collection set, there was one (1) device that the spring popped out when the needle sheath was removed.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: e4: fda notified? yes h10: related report number: (b)(4).Investigation summary: bd did not receive any samples or photos for investigation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.Based on the severity and low defect rate; further testing is not required at this time.This complaint has not been confirmed for the indicated failure mode: spring pop out.No definitive root cause could be established for the reported defect.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: BLOOD SPECIMEN COLLECTION DEVICE; 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: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23408395
• Report Number: 1024879-2025-01664
• Device Sequence Number: 15719957
• Product Code: FPA
• UDI-Device Identifier: 00382903673636
• UDI-Public: (01)00382903673636(11)241028(17)261031(10)4302903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/25/2026

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: 367363
• Device Lot Number: 4302903
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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