MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG; BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING

Catalog Number	362799
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received a photo for investigation.Upon evaluation, no issues were identified.The symbol shown on the shelf pack label and the number on the instructions for use indicate that, after mixing, the whole blood specimen may be stored for up to six hours at room temperature until centrifugation.Additionally, the retained shelf pack label was visually inspected, and no issues were found.The instructions for use (ifu) state: ¿after mixing, the whole blood specimen may be stored up to six (6) hours at room temperature until centrifugation.¿ 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 not been confirmed for the indicated failure mode: incorrect/missing label information.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.
Event or Problem Description
It was reported that when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg, there is a discrepancy between the instructions for use (ifu) and labeling.The customer reported that the ifu states that the sample is to be processed within 2 hours of collection while the product label states that the sample is to be processed within 6 hours of collection.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received a photo for investigation.Upon evaluation, no issues were identified.The symbol shown on the shelf pack label and the number on the instructions for use indicate that, after mixing, the whole blood specimen may be stored for up to six hours at room temperature until centrifugation.Additionally, the retained shelf pack label was visually inspected, and no issues were found.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 not been confirmed for the indicated failure mode: incorrect/missing label information.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.
Event or Problem Description
It was reported that when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg, there is a discrepancy between the instructions for use (ifu) and labeling.The customer reported that the ifu states that the sample is to be processed within 2 hours of collection while the product label states that the sample is to be processed within 6 hours of collection.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG
• Common Device Name: BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• 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: 23716173
• Report Number: 1917413-2025-01615
• Device Sequence Number: 10275172
• Product Code: PJE
• UDI-Device Identifier: 30382903627999
• UDI-Public: (01)30382903627999(17)251231(10)4344923
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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