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

Model Number 762165

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

It was reported when using the paxgene® blood rna tube was placed at -20°c overnight and they did not freeze.After this the tubes were transferred to a different freezer and the blood freeze normally.The following information was provided by the initial reporter.The customer stated: "the tubes were placed at -20°c overnight and they did not freeze.After this the tubes were transferred to a different freezer and the blood freeze normally.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary bd did not receive samples or photographs from the customer in support of this complaint.Customer commented that the first freezer did not freeze tubes, but the other one did.Unfortunately there is not test method in plant for this defect.Bd was unable to duplicate or confirm the customer¿s indicated failure mode.No root cause could be established for the reported defect.Also there were customers comments that the tube was used to freeze urine.This is classed as of label use.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.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 identification of emerging trends.

Event Description

It was reported when using the paxgene® blood rna tube was placed at -20°c overnight and they did not freeze.After this the tubes were transferred to a different freezer and the blood freeze normally.The following information was provided by the initial reporter.The customer stated: "the tubes were placed at -20°c overnight and they did not freeze.After this the tubes were transferred to a different freezer and the blood freeze normally.".

• Brand Name: PAXGENE® BLOOD RNA TUBE
• Type of Device: RNA PREANALYTICAL SYSTEMS
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14959427
• MDR Text Key: 297985133
• Report Number: 9617032-2022-00623
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: 762165
• Device Catalogue Number: 762165
• Device Lot Number: 1021357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1