MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® PLUS CITRATE TUBE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	363048
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	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter addr 1: (b)(6).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
It was reported while using bd vacutainer® plus citrate tube, 2 samples at different collection levels(but still between minimum and maximum collection volume) produced 2 different aptt results - 26.9 versus 28.1.Results were reported to clinician.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received five photos for investigation.The evaluation of the photos did not showcase any additive abnormalities.The photo shows 2 tubes drawn within specification limits.Additionally, 100 retention samples of the incident lot were selected from bd inventory for visual inspection and no issues were observed.Factors that may contribute to erroneous results 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 exhibited proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (erroneous results-aptt) because the defect was not evident in the testing of the complaint lot samples.Replicates of testing perform on both retention and control samples were acceptable in terms of both precision and accuracy.All samples demonstrated clinically acceptable performance for all visual observations evaluated.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is not confirmed with respect to erroneous results-aptt.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported while using bd vacutainer® plus citrate tube, 2 samples at different collection levels(but still between minimum and maximum collection volume) produced 2 different aptt results - 26.9 versus 28.1.Results were reported to clinician.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® PLUS CITRATE TUBE
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22014025
• Report Number: 9617032-2025-00870
• Device Sequence Number: 5228796
• Product Code: JKA
• UDI-Device Identifier: 50382903630481
• UDI-Public: (01)50382903630481(11)250113(17)250930(10)5013965
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K013971
• 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
• Report Date (Section B): 07/25/2025

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: 09/30/2025
• Device Catalogue Number: 363048
• Device Lot Number: 5013965
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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