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

Catalog Number 762165

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.

Event Description

It was reported that paxgene® blood rna tubes were giving erroneous results (lower rin values).However it should be noted that the tubes were expired when used.

Manufacturer Narrative

The 510(k)# was changed to den050003.

• 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
• MDR Report Key: 7532194
• MDR Text Key: 108986823
• Report Number: 9617032-2018-01272
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 762165
• Device Lot Number: 4244464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other