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

Catalog Number 363095

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/30/2018

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 was reported that paxgene® blood rna tube contained foreign matter.No serious injury or medical intervention was reported.

Manufacturer Narrative

Bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for foreign matter with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the issue relating to foreign matter was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Based on evaluation of the customer photos, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Evaluation of the customer samples was conducted and foreign matter was observed.Additionally, evaluation of the retain samples was conducted and foreign matter was not observed.Based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that paxgene blood rna tube contained foreign matter.No serious injury or medical intervention was reported.

• 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: 7926110
• MDR Text Key: 122464650
• Report Number: 9617032-2018-02825
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 363095
• Device Lot Number: 8033829
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other