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

Catalog Number	367326
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using one bd vacutainer® push button blood collection set, blood leaked all over the holder.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.E1: initial reporter facility name: (b)(6).
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: 02-jun-2025.Investigation summary bd received one sample and 5 photos for investigation.Evaluation of the photos shows the reported issue.The returned sample underwent a visual inspection for leakage around the male/female luer connection and failed due to a visible hole.Additionally, a total of 100 retained samples were visually tested for cut and severed tubing; all samples passed, exhibiting no signs of cut or severed tubing.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.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 while using one bd vacutainer® push button blood collection set, blood leaked all over the holder.There was no health impact or consequence reported.
Event or Problem Description
It was reported that while using one bd vacutainer® push button blood collection set, blood leaked all over the holder.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: bd received 1 sample and 5 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for leakage was observed.Additionally, the customer sample was evaluated by visual examination and the indicated failure mode for leakage with the incident lot was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for 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: 22183866
• Report Number: 1024879-2025-00819
• Device Sequence Number: 12904330
• Product Code: FPA
• UDI-Device Identifier: 30382903673262
• UDI-Public: (01)30382903673262(11)240130(17)260131(10)4030226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 11/24/2025

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: 01/31/2026
• Device Catalogue Number: 367326
• Device Lot Number: 4030226
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 11/24/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 11/21/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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