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

Catalog Number 762165

Device Problem Break (1069)

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

Event Date 04/16/2019

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 that 20 paxgene® blood rna tubes cracked after use, exposing the staff to blood, though they reportedly wore ppe and were not sent for testing.This complaint was created to capture 1 of 2 related incidents.The following information was provided by the initial reporter: "stated she is experiencing cracking of tubes after use, workers were exposed to blood but no testing was done." "worker was not sent for testing.Ppe was exposed to blood.".

Event Description

It was reported that 20 paxgene® blood rna tubes cracked after use, exposing the staff to blood, though they reportedly wore ppe and were not sent for testing.This complaint was created to capture 1 of 2 related incidents.The following information was provided by the initial reporter: "stated she is experiencing cracking of tubes after use, workers were exposed to blood but no testing was done." "worker was not sent for testing.Ppe was exposed to blood.".

Manufacturer Narrative

Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, 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.

• 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: 8573700
• MDR Text Key: 145538997
• Report Number: 9617032-2019-00532
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 762165
• Device Lot Number: 8081587
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other