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 03/08/2023

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 that after centrifugation with paxgene® blood rna tube the rna pellets were not able to resuspend, it was a "tar" like substance that would not be dissolved by water.There was no report of patient impact.The following information was provided by the initial reporter: we recently used the paxgene rna stabilizing tubes for blood collection and i had an issue when collecting the crude rna that wasn¿t covered for any troubleshooting guides.First, the crude rna pellets that were collected after the first centrifugation were not able to be fully resuspended.There was almost like a tar substance that would not be dissolved by water.I would vortex for minutes at a time without any progress on dissolving the pellet.Additionally, after the proteinase treatment and 16,000 x g centrifugation, there were some samples that did not pellet the debris.The debris was a mass of slime and so i could not retrieve the 180l back out of my rna sample.I tried to perform the centrifugation again, but it did fully resolve the issue.

Event Description

It was reported that after centrifugation with paxgene® blood rna tube the rna pellets were not able to resuspend, it was a "tar" like substance that would not be dissolved by water.There was no report of patient impact.The following information was provided by the initial reporter: we recently used the paxgene rna stabilizing tubes for blood collection and i had an issue when collecting the crude rna that wasn't covered for any troubleshooting guides.First, the crude rna pellets that were collected after the first centrifugation were not able to be fully resuspended.There was almost like a tar substance that would not be dissolved by water.I would vortex for minutes at a time without any progress on dissolving the pellet.Additionally, after the proteinase treatment and 16,000 x g centrifugation, there were some samples that did not pellet the debris.The debris was a mass of slime and so i could not retrieve the 180 ¿l back out of my rna sample.I tried to perform the centrifugation again, but it did fully resolve the issue.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 100 retention samples from bd inventory were visually inspected with no issues identified.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.The bd ifu (instructions for use) does not provide for any specific yield claims.Yields depend on the patient, the quality of the specimen, and the method used for isolation.A review of the ifu is recommended.This complaint is unable to be confirmed for low yield.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.A bd expert for paxgene was provided customer information so he and qiagen team can review process with customer.

• 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 ; 8448235433
• MDR Report Key: 16640987
• MDR Text Key: 312358520
• Report Number: 9617032-2023-00316
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: (01)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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 762165
• Device Catalogue Number: 762165
• Device Lot Number: 1270374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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