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

Catalog Number	367335
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).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 one bd vacutainer® push button blood collection set, blood spill in the kidney dish while interchanging tubes due to the non-patient needle sleeve puncturing and leaking blood.No patient or user impact reported.
Event or Problem Description
It was reported that while using one bd vacutainer® push button blood collection set, blood spill in the kidney dish while interchanging tubes due to the non-patient needle sleeve puncturing and leaking blood.No patient or user impact reported.
Additional Manufacturer Narrative
Investigation summary bd received three photos for investigation.One of the customer photos shows a device with blood leakage in the holder and a sleeve that is side pierced.Additionally, 30 retained samples were subjected to sleeve function testing and another 30 retained samples were subjected to retraction lockout testing.No issues were observed relating to sleeve leakage as all samples met specifications.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 leakage.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® 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: 21739258
• Report Number: 1024879-2025-00406
• Device Sequence Number: 4046203
• Product Code: FPA
• UDI-Device Identifier: 30382903673354
• UDI-Public: (01)30382903673354(11)230426(17)250430(10)3116662
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220212
• 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): 09/26/2025

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: 04/30/2025
• Device Catalogue Number: 367335
• Device Lot Number: 3116662
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• 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