MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD RNA TUBE; EVACUATED BLOOD COLLECTION TUBE IVD, NUCLEIC ACID STABILIZER

Catalog Number	762165
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported when using the paxgene® blood rna tube, the tube underfilled due to low vacuum.There was no health impact or consequences reported.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in duplicate of report 1917413-2024-00328.Therefore, this mdr will be canceled.
Event or Problem Description
It was reported when using the paxgene® blood rna tube, the tube underfilled due to low vacuum.There was no health impact or consequences reported.

• Brand Name: PAXGENE® BLOOD RNA TUBE
• Common Device Name: EVACUATED BLOOD COLLECTION TUBE IVD, NUCLEIC ACID STABILIZER
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19824452
• Report Number: 9617032-2024-01113
• Device Sequence Number: 8684638
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: (01)54053727621653
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/08/2024

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: 12/31/2024
• Device Catalogue Number: 762165
• Device Lot Number: 3094580
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2023
• 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