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

Catalog Number 762165

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the paxgene® blood rna tube has been found experiencing three occurrences of cracked tubes during use.The following has been provided by the initial reporter: 3 tubes from the same lot number, have during freezing to -20 degrees celsius for 72 hours, cracked in the hemogard.The stopper and the tube is still intact.In this batch , there was tubes from two different lot numbers, the 3 tubes cracked were all from the same lot and the rest from another lot.

Manufacturer Narrative

Investigation: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for cracked cap with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.

Event Description

It has been reported that the paxgene® blood rna tube has been found experiencing three occurrences of cracked tubes during use.The following has been provided by the initial reporter: 3 tubes from the same lot number, have during freezing to -20 degrees celsius for 72 hours, cracked in the hemogard.The stopper and the tube is still intact.In this batch , there was tubes from two different lot numbers, the 3 tubes cracked were all from the same lot and the rest from another lot.

• 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
• MDR Report Key: 9161959
• MDR Text Key: 186756700
• Report Number: 9617032-2019-01132
• Device Sequence Number: 1
• Product Code: NTW
• Combination Product (y/n): N
• PMA/PMN Number: DEN050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 762165
• Device Lot Number: 8284953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other