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

Catalog Number	367344
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows.D.2.B medical device type: jka.D.2.A common device name: tubes, vials, systems, serum separators, blood collection.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Report 2 of 11: it was reported while using bd vacutainer® push button blood collection set, blood splattered during sample collection of one patient when the safety device was activated.No adverse impact was reported regarding the patient or user.
Event or Problem Description
Report 2 of 11.It was reported while using bd vacutainer® push button blood collection set, blood splattered during sample collection of one patient when the safety device was activated.No adverse impact was reported regarding the patient or user.
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: 19-jan-2026.Investigation summary: bd received 10 samples and one photo for investigation.The customer-provided photo shows the device packaging but does not display the reported defect.A total of 10 returned samples were subjected to functional tests to assess splatter during use, and all samples passed with no signs of defects, leakage, or splatter.Additionally, these 10 samples underwent further functional tests for retraction lockout, and all samples passed as they were able to be activated properly with no evidence of defects, leakage, or splatter.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 not been confirmed for the indicated failure mode: splatter.Complaints received for this device and reported condition will continue to be tracked and trended.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: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24254241
• Report Number: 1024879-2026-00082
• Device Sequence Number: 15512319
• Product Code: FPA
• UDI-Device Identifier: 30382903673446
• UDI-Public: (01)30382903673446(11)250521(17)270430(10)5141235
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 367344
• Device Lot Number: 5141235
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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