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

Catalog Number	362760
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D4.Medical device expiration date: unknown h4.Device manufacture date: unknown 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 2 of 2: it was reported while using bd vacutainer® cpt¿ cell preparation tube with sodium citrate, an unspecified number of samples exhibited poor barrier centrifugation.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary : bd received 2 photos for investigation.Evaluation of the 2 photos confirmed the presence of poor barrier separation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.Complaints for sample quality were not under statistical control for the month of september 2025 therefore additional testing is indicated.Factors that may contribute to poor barrier separation were evaluated through a clinical study to verify the design of the device met it¿s intended use.Bd was unable to duplicate or confirm the customer¿s indicated failure (poor barrier separation) because the defect was not evident in the testing of the complaint lot samples.Replicates of both retention and control samples tested demonstrated clinically acceptable performance for all visual observations evaluated.All tubes performed as expected.This complaint has been confirmed for the indicated failure mode poor barrier separation based on the photo provided.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.Our business team regularly reviews the collected data for the identification of emerging trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
Report 2 of 2: it was reported while using bd vacutainer® cpt¿ cell preparation tube with sodium citrate, an unspecified number of samples exhibited poor barrier centrifugation.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: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23358999
• Report Number: 1917413-2025-01456
• Device Sequence Number: 9091560
• Product Code: JCF
• UDI-Device Identifier: 30382903627609
• UDI-Public: (01)30382903627609
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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 Catalogue Number: 362760
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/16/2026
• 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