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

Catalog Number	367985
Medical Device Problem Codes	Short Fill (1575); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 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¿, four tubes underfilled and one tube exhibited foreign matter.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported while using bd vacutainer® sst¿, four tubes underfilled and one tube exhibited foreign matter.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: 15-dec-2025.Investigation summary: bd received 9 samples and 2 photos for investigation.The photos were reviewed and 2 tubes exhibited underfill, 1 tube exhibited burnt plastic at the bottom of the tube, and 7 tubes showed signs of collapse.The nine returned samples along with 30 retained samples were visually inspected.Four of the 9 returned samples exhibited collapse.No other defects were observed in the returned or retained samples.Additionally, 5 of the returned samples and 20 retained samples were functionally tested for draw volume and all tubes tested within specification requirements.The 4 returned samples that were collapsed were not used for functional tests.A review of the device history record indicated a quality notification was raised for the plastic components used for this batch.However, product was dispositioned according to procedure and lot passed all in-process and final quality checks for lot release.This complaint has been confirmed for the indicated failure modes: collapse, underfill, and foreign matter(burnt plastic).No definitive root cause could be established for the reported defect.Based on the low defect rate for the batch in question, no actions are planned at this time 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® SST¿
• 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: 23761955
• Report Number: 1024879-2025-02024
• Device Sequence Number: 13280829
• Product Code: JKA
• UDI-Device Identifier: 30382903679851
• UDI-Public: (01)30382903679851(17)260630(10)5189431
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/23/2026

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: 06/30/2026
• Device Catalogue Number: 367985
• Device Lot Number: 5189431
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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