MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES; CONTAINER, SPECIMEN, STERILE

Catalog Number	366408
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using bd vacutainer® no additive (z) plus tubes for aliquots, an unspecified number of tubes have stoppers that are not staying on after stopper is removed and re-applied.There was no health impact or consequences reported.
Event or Problem Description
It was reported while using bd vacutainer® no additive (z) plus tubes for aliquots, an unspecified number of tubes have stoppers that are not staying on after stopper is removed and re-applied.There was no health impact or consequences 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: 12-may-2025 investigation summary bd received 11 samples for investigation.Functional tests were conducted on these customer samples, and 5 out of the 11 samples showed stopper function defects.Retained samples were not tested as the complaint was confirmed based on the returned samples.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: stopper creep out.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® NO ADDITIVE (Z) PLUS TUBES
• Common Device Name: CONTAINER, SPECIMEN, STERILE
• 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: 22021922
• Report Number: 1024879-2025-00660
• Device Sequence Number: 18512749
• Product Code: FMH
• UDI-Device Identifier: 30382903664086
• UDI-Public: (01)30382903664086(11)241106(17)260331(10)4311685
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• 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): 07/30/2025

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: 03/31/2026
• Device Catalogue Number: 366408
• Device Lot Number: 4311685
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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