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

Catalog Number 762165

Device Problem Short Fill (1575)

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

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the paxgene® blood rna tube there low or no draw.This occurred on 4 separate occasions but the date/time and or patient information is unknown.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: during use, the customer found 4ea tubes have low or no draw issue.

Manufacturer Narrative

Investigation summary: 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 low or no draw with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the issue relating to low or no draw was not 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-conformances during manufacturing of the product.

Event Description

It was reported that during use of the paxgene® blood rna tube there low or no draw.This occurred on 4 separate occasions but the date/time and or patient information is unknown.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: during use, the customer found 4ea tubes have low or no draw issue.

• 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: 8911280
• MDR Text Key: 155978722
• Report Number: 9617032-2019-00952
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 762165
• Device Lot Number: 8177854
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other