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

Catalog Number	362799
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
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.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 prior to use of bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg, 1 tube contained foreign matter in the gel.There was no health impact or consequences reported.
Event or Problem Description
It was reported prior to use of bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg, 1 tube contained foreign matter in the gel.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received three photos for investigation, which show brown streaks in the sidewall and bottom of the tube, identified as embedded foreign material (fm).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: foreign matter-unknown.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.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 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: 22940204
• Report Number: 1917413-2025-01173
• Device Sequence Number: 21271046
• Product Code: PJE
• UDI-Device Identifier: 30382903627999
• UDI-Public: (01)30382903627999(17)251231(10)4344923
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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): 09/26/2025

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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/23/2025
• 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