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

Catalog Number	367989
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after using bd vacutainer® sst¿ blood collection tubes, there was red cell hang-up seen in three (3) tubes.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.
Additional Manufacturer Narrative
Investigation summary: bd received 1 photo for investigation, which showed customer indicated failure mode: red cell hangup.Complaints for sample quality were not under statistical control for the month of january 2026, additional testing was performed.Factors that may contribute to red cell hang up were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.No difficulties were encountered during blood collection, and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure mode, red cell hang up, because the defect was not evident in the testing of the complaint lot samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.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: red cell hang up via photo analysis.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.
Event or Problem Description
It was reported after using bd vacutainer® sst¿ blood collection tubes, there was red cell hang-up seen in three (3) tubes.No adverse impact was reported regarding the patient or user.

• 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: 24406107
• Report Number: 1024879-2026-00230
• Device Sequence Number: 10113473
• Product Code: JKA
• Combination Product (Y/N): N
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2026

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: 05/31/2026
• Device Catalogue Number: 367989
• Device Lot Number: 5153542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 05/01/2026; Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/05/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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