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

Catalog Number 762165

Device Problem Shipping Damage or Problem (1570)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that despite being stored at -20°c for 24 hours 2 paxgene® blood rna tube did not freeze.The following information was provided by the initial reporter, translated from spanish to english: paxgene tubes did not freeze despite being stored at -20°c for 24 hours.The week of (b)(6), we detected that 2 paxgene tubes did not freeze despite being stored at -20°c for 24 hours.Both tubes were from lot 1336881, whose expiration date is the end of september.To better understand the nature of this problem, we carried out a series of additional tests with paxgene tubes (only with the reagent as we did not have sample to fill them), which involved temperature changes prior to freezing at -20°c to try to obtain some information about the source of the problem, and we also did this with tubes from the same lot (1336881) and also from another lot (1167603).The results of these tests revealed that all the tubes froze properly.However, the tube that was subjected to 37°c for several hours and subsequently to -20°c did not freeze at the same rate as the others, but took significantly longer to achieve this.To better understand the nature of this problem, we carried out a series of additional tests with paxgene tubes (only with the reagent as we did not have sample to fill them), involving temperature changes (freeze-thaw, temperature rise over a long period and combination of these factors) prior to freezing at -20ºc to try to get some insight into where the problem came from, and we did this with tubes from the same lot (1336881) and also from another lot (1167603).The results of these tests revealed that the tubes from the same batch as the problematic samples froze properly.However, the tube that was subjected to 37°c for several hours and subsequently to -20°c did not freeze at the same rate as the others, but took significantly longer to achieve this.This could be compatible with overheating during sample transport (since it happened in august), it showed delayed freezing compared to the others, even after reaching adequate temperatures in the freezer.This would be a possibility, but we would like to clarify if indeed elevated temperatures during transport can affect the reagent integrity of the paxgene tubes or if there might be a specific problem with this batch of tubes.Any problems with the paxgene tubes have a significant impact on our work as a biobank as they may negatively affect the integrity of our stored biological samples.Therefore, we request your assistance in addressing this issue and ensuring the quality and reliability of the products supplied by your company.We are willing to provide any additional information or data you may need to investigate this matter thoroughly.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.D10: device available for evaluation: yes d10: returned to manufacturer on: 24-oct-2023.H.6.Investigation summary: material #: 762165.Lot/batch #: 1336881.Bd received 6 samples for investigation.The samples were evaluated by visual examination only as there is not test method functional testing at the plant.The indicated failure mode for not freezing with the incident lot was not observed as all product specifications were met.Product expired 30/09/2023.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.This complaint is unable to be confirmed for the indicated failure mode not freezing.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported that despite being stored at -20°c for 24 hours 2 paxgene® blood rna tube did not freeze.The following information was provided by the initial reporter, translated from spanish to english: paxgene tubes did not freeze despite being stored at -20°c for 24 hours.The week of august 28, we detected that 2 paxgene tubes did not freeze despite being stored at -20°c for 24 hours.Both tubes were from lot 1336881, whose expiration date is the end of september.To better understand the nature of this problem, we carried out a series of additional tests with paxgene tubes (only with the reagent as we did not have sample to fill them), which involved temperature changes prior to freezing at -20°c to try to obtain some information about the source of the problem, and we also did this with tubes from the same lot (1336881) and also from another lot (1167603).The results of these tests revealed that all the tubes froze properly.However, the tube that was subjected to 37°c for several hours and subsequently to -20°c did not freeze at the same rate as the others, but took significantly longer to achieve this.To better understand the nature of this problem, we carried out a series of additional tests with paxgene tubes (only with the reagent as we did not have sample to fill them), involving temperature changes (freeze-thaw, temperature rise over a long period and combination of these factors) prior to freezing at -20ºc to try to get some insight into where the problem came from, and we did this with tubes from the same lot (1336881) and also from another lot (1167603).The results of these tests revealed that the tubes from the same batch as the problematic samples froze properly.However, the tube that was subjected to 37°c for several hours and subsequently to -20°c did not freeze at the same rate as the others, but took significantly longer to achieve this.This could be compatible with overheating during sample transport (since it happened in august), it showed delayed freezing compared to the others, even after reaching adequate temperatures in the freezer.This would be a possibility, but we would like to clarify if indeed elevated temperatures during transport can affect the reagent integrity of the paxgene tubes or if there might be a specific problem with this batch of tubes.Any problems with the paxgene tubes have a significant impact on our work as a biobank as they may negatively affect the integrity of our stored biological samples.Therefore, we request your assistance in addressing this issue and ensuring the quality and reliability of the products supplied by your company.We are willing to provide any additional information or data you may need to investigate this matter thoroughly.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17916631
• MDR Text Key: 326257360
• Report Number: 9617032-2023-01419
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 762165
• Device Lot Number: 1336881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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