MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) VACUTAINER CPT; LYMPHOCYTE SEPARATION MEDIUM

Catalog Number	362753
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 heparin, an unspecified number of tubes exhibited poor barrier separation after processing.Samples were recollected.There was no other 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: 02-oct-2025.Investigation summary: bd received five samples and 15 photos for investigation.The samples were visually inspected with no issues identified.The evaluation of the photos showed the presence of poor barrier separation.Complaints for sample quality were not under statistical control for the month of september 2025, additional testing was performed.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.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 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 customer return and control samples tested demonstrated clinically acceptable performance for all visual observations evaluated.All tubes performed as expected.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 been confirmed for the indicated failure mode: poor barrier separation based on the photos 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.
Event or Problem Description
It was reported while using bd vacutainer® cpt¿ cell preparation tube with sodium heparin, an unspecified number of tubes exhibited poor barrier separation after processing.Samples were recollected.There was no other health impact or consequences reported.

• Brand Name: VACUTAINER CPT
• 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: 23356911
• Report Number: 1917413-2025-01452
• Device Sequence Number: 15753602
• Product Code: JCF
• UDI-Device Identifier: 30382903627531
• UDI-Public: (01)30382903627531(17)260131(10)5020005
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/25/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 362753
• Device Lot Number: 5020005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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