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

Catalog Number 762165

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: tech services spoke with the customer.Explained that she needs to freeze the tubes in a step down process, first to -20c for 24 hours, and then move them to -80c in a non-styrofoam rack.If she didn't allow the tubes to sit at rt to allow for cell lysis after the tube were initially drawn, she can allow them to sit after the tubes have thawed out.She found the handbook on the preanalytix.Com website.The glass tubes were cracking due to the customer not following the step down freezing process.Tech services spoke with the customer and informed them of the correct process to not crack the tubes.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 tubes samples not stored at proper temperature and there was glass breakage during use.The following information was provided by the initial reporter: the customer is experiencing glass breakage when freezing tubes at -80 celsius.There is no specific lot number associated with incidents.The customer believes the fault is of their own accord so we wants to verify how exactly she should be freezer these specimens using this product, if at all.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10231420
• MDR Text Key: 198599473
• Report Number: 9617032-2020-00543
• Device Sequence Number: 1
• Product Code: NTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• 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: 06/25/2020
• 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