MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367819
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® serum plus blood collection tubes, the caps of three tubes were loose.In one instance, the cap came off during inversion and mixing, resulting in exposure.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6) hospital.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9: device available for evaluation: yes.H.3: device eval by manufacturer? yes.D9: returned to manufacturer on: 08-dec-2025.H.1: imdrf annex e grid (1): e2105 - exposure to body fluids.Investigation summary: bd received 1 sample and 4 photos for investigation.The photos show a tube without its cap assembly.However, the photos did not provide sufficient evidence to confirm the reported defect based on the photos.Additionally, 29 retention samples from bd inventory, were functionally evaluated for stopper function and 10 failed testing.The customer returned sample was not evaluated since retain testing confirmed the defect.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 stopper creepout/loose stopper.Bd has initiated further root cause investigation relating to the issue of stopper function through corrective and preventive actions.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.
Event or Problem Description
It was reported while using bd vacutainer® serum plus blood collection tubes, the caps of three tubes were loose.In one instance, the cap came off during inversion and mixing, resulting in exposure.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: 23778631
• Report Number: 1024879-2025-02063
• Device Sequence Number: 10345505
• Product Code: JKA
• UDI-Device Identifier: 30382903678199
• UDI-Public: (01)30382903678199(17)260831(10)5098261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK050036
• 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): 03/03/2026

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: 367819
• Device Lot Number: 5098261
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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