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

Catalog Number	362753
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 that when using the bd vacutainer® cpt¿ cell preparation tube with sodium heparin there was a defective cap molding observed.After use, one cpt blood collection tube (lot: 5069090) customer found to have a large, chipped rubber stopper.It is assumed that the chip was there from the beginning.
Additional Manufacturer Narrative
The mdr submitted with mfr report #: 2243072-2025-01391 was submitted with the incorrect site registration number.This mdr is now void and an mdr with the correct site registration number will be submitted.
Event or Problem Description
It was reported that when using the bd vacutainer® cpt¿ cell preparation tube with sodium heparin there was a defective cap molding observed.After use, one cpt blood collection tube (lot: (b)(4)) customer found to have a large, chipped rubber stopper.It is assumed that the chip was there from the beginning.

• Brand Name: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
• 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: 23527361
• Report Number: 2243072-2025-01391
• Device Sequence Number: 18427172
• Product Code: JCF
• UDI-Device Identifier: 30382903627531
• UDI-Public: (01)30382903627531(17)260331(10)5069090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 03/31/2026
• Device Catalogue Number: 362753
• Device Lot Number: 5069090
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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