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

Catalog Number 363095

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

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

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported with the use of the paxgene® blood rna tube there was an issue with underfill.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for underfill with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the issue relating to underfill 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.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for underill with the incident lot was not observed.Evaluation/testing of the retain samples was also conducted and underfill was observed.Further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: a capa has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.

Event Description

It was reported with the use of the paxgene® blood rna tube there was an issue with underfill.There was no report of injury or medical intervention.

• 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: 7981798
• MDR Text Key: 124501689
• Report Number: 9617032-2018-02912
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 363095
• Device Lot Number: 8144657
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other