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

Model Number 762165

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Component Missing (2306)

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

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported when using the bd paxgene® blood rna tube, the device experienced discolored or abnormal additive form and missing additive.The following information was provided by the initial reporter.The customer stated: it was reported that white crystal sediment/particulate formed in the last step of the processing.Customer called to report that they are processing the pax gene rna tubes that have been stored in -80 degrees.She said they were collected in 2010 and expired in 2014.She explained that there is a weird particulate forming, looks like white crystals in the last step of the process, she is wanting to know what this might be or maybe due to the age of the tubes.

Event Description

It was reported when using the bd paxgene® blood rna tube, the device experienced discolored or abnormal additive form and missing additive.The following information was provided by the initial reporter.The customer stated: it was reported that white crystal sediment/particulate formed in the last step of the processing.Customer called to report that they are processing the pax gene rna tubes that have been stored in -80 degrees.She said they were collected in 2010 and expired in 2014.She explained that there is a weird particulate forming, looks like white crystals in the last step of the process, she is wanting to know what this might be or maybe due to the age of the tubes.

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

H6: investigation summary bd had not received samples, but 1 video was provided for investigation.The video was reviewed and the indicated failure mode for sediment /crystal formation and low yield was not observed.Retained samples expired, therefore could not be tested.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd has no claims on yield for this product.The technical service guidance provided (through the molecular specialist), is as follows: the expiration date on the tube only pertains to blood collection and not storage.We have 15 year stability of the blood in the tube at -20 and -80c.The white precipitate should not effect downstream rna quality.H3 other text : see h10.

Event Description

It was reported when using the bd paxgene® blood rna tube, the device experienced discolored or abnormal additive form and missing aditive.The following information was provided by the initial reporter.The customer stated: it was reported that white crystal sediment/particulate formed in the last step of the processing.Customer called to report that they are processing the pax gene rna tubes that have been stored in -80 degrees.She said they were collected in 2010 and expired in 2014.She explained that there is a weird particulate forming, looks like white crystals in the last step of the process, she is wanting to know what this might be or maybe due to the age of the tubes.

• 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: 12965215
• MDR Text Key: 285936835
• Report Number: 9617032-2021-01266
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2014
• Device Model Number: 762165
• Device Catalogue Number: 762165
• Device Lot Number: 2241091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2012
• 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