MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE; LYMPHOCYTE SEPARATION MEDIUM

Catalog Number	362761
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
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® cpt¿ cell preparation tube with sodium citrate, an unspecified number of samples exhibited clumping during the cell washing/resuspension phase.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, 60 retention samples from bd inventory were visually inspected with no issues observed.Complaints for sample quality were not under statistical control for the month of march 2025, additional testing may be required: further clinical testing is not indicated as the customer resolved the issue by performing wash steps with the recommended phosphate buffered saline (pbs) solution.No further testing is required.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 unable to be confirmed for the indicated failure mode poor plasma.Bd was not able to identify an exact 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.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported while using bd vacutainer® cpt¿ cell preparation tube with sodium citrate, an unspecified number of samples exhibited clumping during the cell washing/resuspension phase.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
• Common Device Name: LYMPHOCYTE SEPARATION MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21908418
• Report Number: 1917413-2025-00509
• Device Sequence Number: 8795216
• Product Code: JCF
• UDI-Device Identifier: 30382903627616
• UDI-Public: (01)30382903627616(11)240619(17)250630(10)4171844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 05/01/2025

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: 06/30/2025
• Device Catalogue Number: 362761
• Device Lot Number: 4171844
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• 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