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

Catalog Number 762165

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 02/04/2020

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 clotting occurred after use with a paxgene® blood rna tube.The following information was provided by the initial reporter, "customer called for tech support in regards to clotting of specimens.She does have unused tubes to be sent in for investigation.Rna testing was attempted but resulted in abnormally low results for rna.Customer is requesting tech support reach out to her for guidance.Comment type: work performed.Customer is collecting human blood into a sodium heparin tube and transferring to the paxgene rna tube with a syringe and needle.The blood is in the sodium heparin tube for about 24 hours before transferring.When transferred the blood is mixed 6-10 times in the paxgene tube.She states that the clots are pretty solid not microclots.She could not pipette out to do wash step.She does not know why it is happening in some tubes and not others.It is best to draw directly into paxgene tubes and not mix anticoagulant types." 4 occurrences were reported.

Event Description

It was reported that clotting occurred after use with a paxgene® blood rna tube.The following information was provided by the initial reporter, "customer called for tech support in regards to clotting of specimens.She does have unused tubes to be sent in for investigation.Rna testing was attempted but resulted in abnormally low results for rna.Customer is requesting tech support reach out to her for guidance.Comment type: work performed customer is collecting human blood into a sodim heparin tube and transferring to the paxgene rna tube with a syringe and needle.The blood is in the sodium heaprin tube for about 24 hours before transferring.When transferred the blood is mixed 6-10 times in the paxgene tube.She states that the clots are pretty solid not microclots.She could not pipette out to do wash step.She does not know why it is happening in some tubes and not others.It is best to draw directly into paxgene tubes and not mix anticoagulant types." 4 occurrences were reported.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.

• 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: 9757258
• MDR Text Key: 187255894
• Report Number: 9617032-2020-00178
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 762165
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other