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

Catalog Number	366408
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).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 during use of bd vacutainer® no additive (z) plus tubes, an unspecified number of tubes had a loose closure after removing the cap and replacing it resulting in sample leakage.There was no other health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received a video for investigation, which shows a tube being held while the hemogard closure assembly is pushed off the tube with the thumb; however, the video does not demonstrate the indicated failure mode.A total of 100 retained samples were visually inspected and found to have the hemogard closure assembly correctly assembled and placed on the tubes, with no cocked stoppers identified.Additionally, 10 retained samples underwent functional tests, and all were within specification limits.No issues with the hemogard closure assembly being loose or separating were observed during or after the functional tests.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: stopper function.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 during use of bd vacutainer® no additive (z) plus tubes, an unspecified number of tubes had a loose closure after removing the cap and replacing it resulting in sample leakage.There was no other health impact or consequences reported.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES
• Common Device Name: CONTAINER, SPECIMEN, STERILE
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23688415
• Report Number: 1917413-2025-01603
• Device Sequence Number: 5904501
• Product Code: FMH
• UDI-Device Identifier: 30382903664086
• UDI-Public: (01)30382903664086(17)260831(10)5174629
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 366408
• Device Lot Number: 5174629
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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