MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD Vacutainer® SST¿ II Advance; Tubes, vials, systems, serum separators, blood collection

Catalog Number	367955
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient 2 of 13: it was reported that when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, elevated na and k parameters were observed.Upon repeat of the same sample the results were normal.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown lot number was not reported; however, multiple potential lot numbers were provided.The information for these numbers are as follows: d4.Medical device lot #: 5104171 d4.Medical device expiration date: 30-sep-2026 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 14-apr-2025 d4.Medical device lot #: 5157993 d4.Medical device expiration date: 30-nov-2026 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 06-jun-2025 d4.Medical device lot #: 5260068 d4.Medical device expiration date: 30-nov-2026 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 06-jun-2025 d4.Medical device lot #: 6023818 d4.Medical device expiration date: 31-jul-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 23-jan-2026 d4.Medical device lot #: 6034522 d4.Medical device expiration date: 31-jul-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 03-feb-2026 d4.Medical device lot #: 6057402 d4.Medical device expiration date: 31-aug-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 01-mar-2026 d4.Medical device lot #: 6057538 d4.Medical device expiration date: 31-aug-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 01-mar-2026 d4.Medical device lot #: 6057539 d4.Medical device expiration date: 31-aug-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 01-mar-2026 d4.Medical device lot #: 6057540 d4.Medical device expiration date: 31-aug-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 01-mar-2026 d4.Medical device lot #: 6057549 d4.Medical device expiration date: 31-aug-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 26-feb-2026 d4.Medical device lot #: 6086535 d4.Medical device expiration date: 30-sep-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 27-mar-2026 d4.Medical device lot #: 6086583 d4.Medical device expiration date: 30-sep-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 27-mar-2026 d4.Medical device lot #: 6086691 d4.Medical device expiration date: 30-sep-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 27-mar-2026 d4.Medical device lot #: 6117985 d4.Medical device expiration date: 31-oct-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 27-apr-2026 d4.Medical device lot #: 6117990 d4.Medical device expiration date: 31-oct-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 27-apr-2026 d4.Medical device lot #: 6120344 d4.Medical device expiration date: 31-oct-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 30-apr-2026 d4.Medical device lot #: 6146595 d4.Medical device expiration date: 31-oct-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 26-may-2026 d4.Medical device lot #: 6146656 d4.Medical device expiration date: 30-nov-2027 d4.Unique identifier (udi) #: (b)(4) h4.Device manufacture date: 26-may-2026 a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD Vacutainer® SST¿ II Advance
• Common Device Name: Tubes, vials, systems, serum separators, blood collection
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; +1(201)847-5186
• MDR Report Key: 50820950
• Report Number: 9617032-2026-01669
• Device Sequence Number: 18810777
• Product Code: JKA
• UDI-Device Identifier: 30382903679554
• UDI-Public: (01)30382903679554
• 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
• 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: 367955
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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