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 Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd vacutainer® sst¿ blood collection tubes, about twenty (20) tubes that exhibited rough or cracked edges, resulting in blood leakage in the centrifuge.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
After further evaluation of the complaint and information provided during additional follow up, it has been determined that the previously submitted report number 1024879-2026-01608 was sent in error.There was no report of serious injury, or medical intervention.The reported issue has been updated from the additional information provided during follow up.The correct information included in the b5.Describe event field is as follows: it was reported that when using the bd vacutainer® sst¿ blood collection tubes, about twenty (20) tubes that exhibited rough or cracked edges, resulting in blood leakage in the centrifuge.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 ; +1(201)847-5186
• MDR Report Key: 50788751
• Report Number: 1024879-2026-01608
• Device Sequence Number: 13142797
• Product Code: JKA
• UDI-Device Identifier: 30382903679882
• UDI-Public: (01)30382903679882(17)270430(10)6134380
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/18/2026

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 Catalogue Number: 367988
• Device Lot Number: 6134380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2026
• 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