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

Catalog Number	367977
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® sst¿, an unspecified number of tubes are bowed preventing the automated instrument from aspirating the sample properly.There was no health impact or consequences reported.
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 had not received any samples or photos for investigation.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: bowed.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.
Event or Problem Description
It was reported while using bd vacutainer® sst¿, an unspecified number of tubes are bowed preventing the automated instrument from aspirating the sample properly.There was no health impact or consequences reported.
Event or Problem Description
It was reported while using bd vacutainer® sst¿, an unspecified number of tubes are bowed preventing the automated instrument from aspirating the sample properly.There was no health impact or consequences reported.
Additional Manufacturer Narrative
This supplemental mdr is submitted to document that bd will no longer consider the specific malfunction identified below to be a reportable mdr malfunction for the specified product family.Consistent with fda's "medical device reporting for manufacturers" guidance (november 8, 2016, section 2.15), bd determined that this issue has not caused or contributed to a death or serious injury in the previous two years and that the likelihood of a death or serious injury occurring as a result is remote.Bd previously notified fda of this determination on january 8, 2026.Product family: bd vacutainer® sst¿ blood collection tubes specific malfunction: tubes / extenders with molding defects (non-cosmetic) that can be used this mdr is being submitted as a representative notification for the product family and specific malfunction identified above and applies to all applicable catalog numbers within that product family associated with this issue.This determination applies only to the issue identified above when it occurs independently and does not otherwise meet mdr reporting requirements.Bd will continue to submit mdrs for reportable deaths, serious injuries, and reportable malfunctions, including events involving multiple event types where mdr reporting criteria are met.Future occurrences of this issue will no longer be submitted as standalone malfunction mdrs.Bd will continue to monitor complaint and adverse event data related to this issue and will reassess mdr reportability should new information indicate that reporting criteria may be met.

• 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: 24235698
• Report Number: 1024879-2026-00067
• Device Sequence Number: 15695904
• Product Code: JKA
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 09/03/2026

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: 06/30/2026
• Device Catalogue Number: 367977
• Device Lot Number: 5252212
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/09/2026; Not provided
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/07/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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