MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD DNA TUBE; BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING

Catalog Number	761165
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to using paxgene® blood dna tube, 1205 tubes displayed a different lot number than that of the box they were packaged in.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for incorrect label content was observed.Evaluation of the photos indicated that the shelf label had a lot number of 4095154 with an expiration date of 30-apr-2025, and tube labels with a of lot number of 4079048 with an expiration date of 31-may-2025.Additionally, 200 retention samples from bd inventory were evaluated by visual examination and upon completion the indicated failure mode for incorrect label content was not observed.Based on a review of the device history record for the incident lot, some product requirements for lot release were unmet and not discovered prior to release.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode incorrect label information.A global hold has been placed on this batch number.Bd has initiated further root cause investigation relating to the issue of incorrect label content through corrective and preventive actions.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.

• Brand Name: PAXGENE® BLOOD DNA TUBE
• Common Device Name: BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21169069
• Report Number: 9617032-2024-02156
• Device Sequence Number: 11913066
• Product Code: PJE
• UDI-Device Identifier: 04053727611659
• UDI-Public: (01)04053727611659(11)240404(17)250430(10)4095154
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K231469
• 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
• Report Date (Section B): 12/24/2024

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: 04/30/2025
• Device Catalogue Number: 761165
• Device Lot Number: 4095154
• 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: 12/18/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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