MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON; 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	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before using bd vacutainer® ultratouch¿ push button, the customer found the needle was found exposed due to puncture through its rubber cover.There was no health impact or consequence reported.
Additional Manufacturer Narrative
D.2b medical device type: one additional code applies; jka a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd received two photos for investigation.One customer photo shows a device with the cannula pierced through the side of the sleeve.Additionally, 30 retained samples underwent functional tests.All the samples passed testing as there was no evidence of side pierced sleeves, poor sleeve recovery, or sleeve leakage during the draw.Furthermore, the 30 retained samples were subjected to additional functional tests.The samples passed testing as there was no leakage observed during retraction.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.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.
Event or Problem Description
It was reported that before using bd vacutainer® ultratouch¿ push button, the customer found the needle was found exposed due to puncture through its rubber cover.There was no health impact or consequence reported.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON
• 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: 22339042
• Report Number: 1024879-2025-00899
• Device Sequence Number: 15802847
• Product Code: FPA
• UDI-Device Identifier: 30382903673637
• UDI-Public: (01)30382903673637(11)250404(17)270331(10)5094074
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 11/06/2025

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: 5094074
• 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: 06/01/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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