MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	362799
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter addr 1: (b)(6).E1.Initial reporter facility name: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Report 1 of 4, it was reported while using bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg, poor gel quality was seen in an unspecified number of tubes.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received 1 photo for investigation.Visual examination of the photo revealed a sample with poor barrier separation.Additionally, 100 retention samples from bd inventory were visually inspected with no issues identified.Complaints for sample quality are under statistical control for the month of june 2025.At this time, further testing is not indicated.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 has been confirmed for poor barrier separation based on the photo provided.Retention samples testing revealed no tube defects.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 identification of emerging trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
Report 1 of 4 it was reported while using bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg, poor gel quality was seen in an unspecified number of tubes.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 22591902
• Report Number: 1917413-2025-00964
• Device Sequence Number: 9128902
• Product Code: PJE
• UDI-Device Identifier: 30382903627999
• UDI-Public: (01)30382903627999(17)251231(10)4344923
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K972075
• 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): 08/01/2025

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: 12/31/2025
• Device Catalogue Number: 362799
• Device Lot Number: 4344923
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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