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

Catalog Number	367988
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® sst¿ blood collection tubes, an unspecified number of tubes underfilled and experienced poor barrier separation.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma/510(k)#: k230855.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
It was reported while using bd vacutainer® sst¿ blood collection tubes, an unspecified number of tubes underfilled and experienced poor barrier separation.No adverse impact was reported regarding the patient or user.
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: 23-mar-2026.Investigation summary: bd received 28 samples for investigation.All 28 samples were visually inspected for gel defects, and one sample was found to have an air bubble in the gel.Additionally, 20 of the 28 returned samples were randomly selected for functional tests related to low or no draw, and all tubes were within specification.Complaints for sample quality are under statistical control for the month of february 2026.At this time, further testing is not indicated.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 been confirmed for the indicated failure modes: poor barrier separation and underfill.This complaint has been confirmed for gel air bubbles.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.Our business team regularly reviews the collected data for the identification of emerging trends.Bd quality will continue to monitor sample quality complaints.

• Brand Name: BD VACUTAINER® SST¿ 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: 24576930
• Report Number: 1024879-2026-00337
• Device Sequence Number: 10391963
• Product Code: JKA
• UDI-Device Identifier: 30382903679882
• UDI-Public: (01)30382903679882(17)260831(10)5255884
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 367988
• Device Lot Number: 5255884
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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