MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E (EDTA) 9.0 MG; BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING

Catalog Number	362791
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
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 during use of bd vacutainer® ppt¿ plasma preparation tubes k2e (edta) 9.0 mg, 5 tubes exhibited poor plasma (floaties in the plasma).There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples for investigation.100 retained samples were visually inspected with no issues observed.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 january 2025; additional testing may be required: further clinical testing could not be conducted as the tubes were expired at the time of review.Clinical evaluation cannot be conducted on expired tubes.This complaint has not been confirmed for the indicated failure mode: poor plasma.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.Information will be captured on trend reports and monitored.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
It was reported during use of bd vacutainer® ppt¿ plasma preparation tubes k2e (edta) 9.0 mg, 5 tubes exhibited poor plasma (floaties in the plasma).There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E (EDTA) 9.0 MG
• Common Device Name: BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
• 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: 21376409
• Report Number: 1917413-2025-00112
• Device Sequence Number: 20988571
• Product Code: PJE
• UDI-Device Identifier: 50382903627917
• UDI-Public: (01)50382903627917(11)240111(17)250131(10)4011394
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/22/2025

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: 01/31/2025
• Device Catalogue Number: 362791
• Device Lot Number: 4011394
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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