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

Catalog Number 762165

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

H.6.Investigation summary: material #: 762165.Lot/batch #: unknown.Bd had not received samples or photos 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.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.

Event Description

It was reported when using the paxgene® blood rna tube blood flowed back into patient's vein.The following information was provided by the initial reporter.The customer stated: customer reports that during venipuncture there was an issue with the tube and blood flowed back into patient's vein.-steps taken with customer/troubleshooting: customer called stating that during blood collection blood came out of the tube and back into the patient's vein.Customer was requesting assistance on how to treat the patient since additive potentially went back into their vein.Customer had reviewed the sds but was unsure how to proceed.Customer could not provide specific tube information except it was the paxgene rna tube.Consulted with bd quality and medical affairs, advised customer to contact poison control.Per customer, they could not provide additional information as the collection was performed by a phlebotomist.Agreed with customer to send email with the questions bd need answers for the investigation.

• 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18066197
• MDR Text Key: 327295631
• Report Number: 9617032-2023-01585
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 00382907621657
• UDI-Public: (01)00382907621657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention