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

Model Number 762165

Device Problem Break (1069)

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

Event Date 08/03/2021

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.Investigation summary: 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.It was noted that the instructions, ''procedure for freezing and thawing specimens collected in the paxgene blood rna tubes," from the information for use (ifu) were not followed.The tubes were left in the styrofoam tray and were not transferred into a wire rack while in the cold room, therefore some of the tubes cracked.Technical services sent an email referring to the faqs for the paxgene rna tube on preanalytix.Com and attempted several follow-ups.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the paxgene® blood rna tube, the device experienced a cracked tube.The following information was provided by the initial reporter.The customer stated: it was reported that tubes cracked in freezer.I found out the hard way that you're not supposed to use styrofoam trays for storage of paxgene blood rna tubes because they can cause the tubes to crack.This actually happened to me when i was sorting some of the paxgene tubes in our cold room (in which i was planning to transfer them to our new metal racks in the -80c freezer).I noticed that some of the tubes i was trying to reorganize had cracked and quickly put everything back into the freezer until we could assess and figure out a solution.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12356864
• MDR Text Key: 267835429
• Report Number: 9617032-2021-00911
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 762165
• Device Catalogue Number: 762165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• 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