MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD RNA TUBE; SEE H11

Catalog Number	762165
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows.D.2.A common device name: system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test.E.1.Initial reporter facility name: (b)(6).There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k082150.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 prior to using paxgene® blood rna tube, seven (7) tubes were found to have cracks in the tube wall.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9.Returned to manufacturer: yes.H.3 device eval by manufacturer? yes.D9.Device available for eval?: 06-feb-2026.Investigation summary: photos of 7 customer returned samples were included for the investigation.Evaluation of the photos indicated a crack/scratch on each of the tube walls.Additionally, 100 retained samples were visually inspected, and no tube damage was observed.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 damaged tube.No definitive root cause could be established for the reported defect.Based on the low defect rate for the batch in question, no actions are planned at this time.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 prior to using paxgene® blood rna tube, seven (7) tubes were found to have cracks in the tube wall.No adverse impact was reported regarding the patient or user.

• Brand Name: PAXGENE® BLOOD RNA TUBE
• Common Device Name: SEE H11
• 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: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24300301
• Report Number: 9617032-2026-00115
• Device Sequence Number: 18488886
• Product Code: NTW
• UDI-Device Identifier: 04053727621658
• UDI-Public: (01)04053727621658(11)240917(17)260430(10)4261187
• 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,Followup
• Report Date (Section B): 02/20/2026

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: 04/30/2026
• Device Catalogue Number: 762165
• Device Lot Number: 4261187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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