MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD RNA TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	762165
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	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported while using paxgene® blood rna tube, there was orange/brown foreign matter inside one tube.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd received one photo for investigation.The photo was reviewed and the indicated failure mode for foreign matter with the incident lot was not observed.Additionally, a total of 100 retained samples were visually observed, and no foreign material was 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: foreign matter.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 while using paxgene® blood rna tube, there was orange/brown foreign matter inside one tube.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported while using paxgene® blood rna tube, there was orange/brown foreign matter inside one tube.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary : bd received two photos for investigation.The photos were reviewed and the indicated failure mode for foreign matter with the incident lot was observed.A total of 100 retained samples were visually observed, and no foreign material was 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 been confirmed for the indicated failure mode: foreign matter.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: PAXGENE® BLOOD RNA TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 22383756
• Report Number: 9617032-2025-01172
• Device Sequence Number: 8761685
• Product Code: NTW
• UDI-Device Identifier: 04053727621658
• UDI-Public: (01)04053727621658(11)240423(17)251231(10)4114043
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K082150
• 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,Followup
• Report Date (Section B): 12/03/2025

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: 762165
• Device Lot Number: 4114043
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 12/03/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/11/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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