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

Catalog Number	368688
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2b medical device type: one additional code applies; jka.A2: patient¿s birthday was not provided, (b)(6) 2024 was used based on age of patient.B3: date of event is unknown.The date received by manufacturer has been used for this field.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using bd vacutainer® ultratouch¿ push button blood collection set with pah, blood started leaking out when the needle was retracted.This has occurred two (2) times and no patient or user impact reported.
Event or Problem Description
It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set with pah, blood started leaking out when the needle was retracted.This has occurred two (2) times and no patient or user impact reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 29-jan-2025.Investigation summary : bd received three photos and six samples for investigation.The customer photos depict a device with blood leakage in the front and rear barrel of the device.The six customer samples underwent functional tests and retraction lockout tests.All samples passed these tests with no evidence of damage to the device or leakage during use, and they were able to be activated properly with no signs of defects or leakage.Additionally, 30 retained samples were subjected to similar functional tests and retraction lockout tests.All retained samples passed these tests, exhibiting no signs of damage or leakage and were able to be activated properly without any defects.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: leakage during use.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.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 WITH PAH
• 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: 21313445
• Report Number: 1024879-2025-00084
• Device Sequence Number: 12799715
• Product Code: FPA
• UDI-Device Identifier: 30382903686880
• UDI-Public: (01)30382903686880(11)240820(17)260731(10)4233124
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/19/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 368688
• Device Lot Number: 4233124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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 Age: 12 MO
• Patient Sex: Unknown