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 Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported during use the paxgene® blood rna tube the tube cracked.The following information was provided by the initial reporter: the customer noticed the tube cracked when removing the tube from the freezer."the tube was used a few years ago and the customer states they have not had an issue with tubes cracking during centrifugation.".

Event Description

It was reported during use the paxgene® blood rna tube the tube cracked.The following information was provided by the initial reporter: the customer noticed the tube cracked when removing the tube from the freezer."the tube was used a few years ago and the customer states they have not had an issue with tubes cracking during centrifugation.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.

• 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: 10202488
• MDR Text Key: 199120741
• Report Number: 9617032-2020-00524
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 762165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other