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

Catalog Number	367977
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	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k)#: one additional code applies; k230855.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Report 5 of 8: it was reported that while using bd vacutainer® sst¿ blood collection tubes, the customer received erroneous results for sodium and other unnamed chemistry assays.The sample was retested multiple times and continued to give higher values.The patient was sent to the emergency room.Upon recollection and retesting the results were normal.The initial results were amended.There were no health impact or consequences reported.
Event or Problem Description
Report 5 of 8 it was reported that while using bd vacutainer® sst¿ blood collection tubes, the customer received erroneous results for sodium and other unnamed chemistry assays.The sample was retested multiple times and continued to give higher values.The patient was sent to the emergency room.Upon recollection and retesting the results were normal.The initial results were amended.There were no health impact or consequences reported.
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: 26-mar-2025 investigation summary bd received one photo and 196 samples for investigation.After analysis, the reported defect was not detected in the customer photo.Out of the 196 customer samples, 30 underwent visual inspection for additive defects, and none failed.Additionally, 30 retained samples were visually inspected for visual defects, and none of these samples failed.Further clinical testing could not be conducted as the tubes were expired at the time of review.Clinical evaluation couldn't be conducted on expired tubes.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: erroneous results -potassium.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.Information will be captured on trend reports and monitored.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., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21179346
• Report Number: 1024879-2025-00020
• Device Sequence Number: 4300899
• Product Code: JKA
• UDI-Device Identifier: 30382903679776
• UDI-Public: (01)30382903679776(11)240502(17)250228(10)4123524
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/27/2025

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: 02/28/2025
• Device Catalogue Number: 367977
• Device Lot Number: 4123524
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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