MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes; Tubes, vials, systems, serum separators, blood collection

Catalog Number	363083
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Report 5 of 10 it was reported that during blood draw of one patient using bd vacutainer® buffered sodium citrate (9nc) blood collection tubes, an unspecified number of tubes overfilled.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.E.1.Initial reporter facility name: (b)(6) hospital d.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown the lot number was not reported; however, two potential lot numbers were provided.The information for that number is as follows: d4.Medical device lot#: 6135940 d4.Medical device expiration date: 28-feb-2027 h4.Device manufacture date: 15-may-2026 d4.Medical device lot#: 6135939 d4.Medical device expiration date: 28-feb-2027 h4.Device manufacture date: 15-may-2026 investigation summary: bd received 2 photos for investigation related to lot numbers 6135939, 6135940 and unknown.Upon evaluation, the photos did not show the customer¿s reported failure mode of overfill.A total of 100 retained samples from both lots were visually inspected, with no issues identified.Functional tests were performed on 10 retained samples from the production lots, and all tubes were found to be within specification limits.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Additionally, an unknown lot number was provided; therefore, a review of the device history record for the unknown lot number could not be conducted.This complaint has not been confirmed for the lots 6135939, 6135940, and unknown, for the indicated failure mode: draw volume.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 the identification of emerging trends.

• Brand Name: BD Vacutainer® Buffered Sodium Citrate (9NC) 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. (Broken Bow); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; +1(201)847-5186
• MDR Report Key: 50900334
• Report Number: 1917413-2026-00906
• Device Sequence Number: 17605599
• Product Code: JKA
• UDI-Device Identifier: 30382903630838
• UDI-Public: (01)30382903630838
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 363083
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• 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