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

Catalog Number 762165

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported when using the paxgene® blood rna tube there was a cracked tube.The following information was provided by the initial reporter and translated to english.The customer stated: "after centrifugation the tube burst.No other adverse effects to patients.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for investigation.Therefore, two hundred (200) retention samples from bd inventory were evaluated by visual examination and no issues were observed as all samples met specifications.Additionally, four (4) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to breakage as all samples met specifications.Zero (0) of the four (4) retention tubes broke, and examination post centrifugation, revealed no signs of cracking.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 notifications.This complaint is unable to be confirmed for the indicated failure mode of tube breakage.Bd was not able to identify a root cause for the indicated failure mode.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12853807
• MDR Text Key: 285702029
• Report Number: 9617032-2021-01195
• Device Sequence Number: 1
• Product Code: NTW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: DEN050003
• 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
• Report Date: 11/02/2021

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
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 762165
• Device Lot Number: 0204816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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