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	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that while using while using one bd vacutainer® ultratouch¿ push button blood collection set with pah, blood started flowing into the gold top tube very slowly, then it started flowing back to the patient.No patient or user impact reported as the nurse removed the vacutainer tube, disconnected the transfer device from the butterfly tubing, and attached the 3 ml syringe to the butterfly tubing to manually withdraw the blood through the butterfly tube.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1024879-2025-00264 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using while using one bd vacutainer® ultratouch¿ push button blood collection set with pah, blood started flowing into the gold top tube very slowly, then it started flowing back to the patient.No patient or user impact reported as the nurse removed the vacutainer tube, disconnected the transfer device from the butterfly tubing, and attached the 3 ml syringe to the butterfly tubing to manually withdraw the blood through the butterfly tube.

• 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: 21548878
• Report Number: 1024879-2025-00264
• Device Sequence Number: 4420135
• Product Code: FPA
• UDI-Device Identifier: 30382903686880
• UDI-Public: (01)30382903686880(11)241118(17)261130(10)4323607
• 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): 10/02/2025

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: 368688
• Device Lot Number: 4323607
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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