MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) PAXGENE® BLOOD RNA TUBE; SEE H.11

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	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b.Common device name: system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test.There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k082150.E.1: initial reporter facility name: (b)(6) university.Investigation summary: bd received a photo for investigation.The attached photo shows the indicated failure mode of fm inside the tube.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements.This complaint has been confirmed for the indicated failure mode: foreign matter - non-biological.No definitive root cause could be established for the reported defect.Based on an evaluation of severity and frequency it was determined that no corrective actions are required.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported that prior to using paxgene® blood rna tube, a foreign object was found inside of one tube.No adverse impact was reported regarding the patient or user.

• Brand Name: PAXGENE® BLOOD RNA TUBE
• Common Device Name: SEE H.11
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 25056838
• Report Number: 9617032-2026-00775
• Device Sequence Number: 21367403
• Product Code: NTW
• UDI-Device Identifier: 04053727621658
• UDI-Public: (01)04053727621658(11)250121(17)260930(10)5021007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: DEN050003
• 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
• Report Date (Section B): 04/04/2026

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: 09/30/2026
• Device Catalogue Number: 762165
• Device Lot Number: 5021007
• 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: 04/02/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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