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

Catalog Number	367363
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2b medical device type: one additional code applies; jka.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using 12 bd vacutainer® ultratouch¿ push button blood collection set, the customer noticed hole in butterfly tubing.No patient or user impact reported.
Event or Problem Description
It was reported that while using 12 bd vacutainer® ultratouch¿ push button blood collection set, the customer noticed hole in butterfly tubing.No patient or user impact reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples for investigation.A total of 30 retained samples were visually inspected, and all samples passed testing with no evidence of damage or holes in the tubing.Additionally, another set of 30 retained samples underwent functional tests to assess the functionality of the device, and all samples passed with no damage to the tubing or leakage observed.Furthermore, a subsequent set of functional tests on 30 retained samples confirmed proper activation with no defects 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 not been confirmed for the indicated failure mode: hole in the tubing.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: 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21574615
• Report Number: 1024879-2025-00278
• Device Sequence Number: 15614999
• Product Code: FPA
• UDI-Device Identifier: 30382903673637
• UDI-Public: (01)30382903673637
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 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 Catalogue Number: 367363
• Device Lot Number: UNKNOWN
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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