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

Catalog Number 762165

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd had not received samples or photos from the customer 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.

Event Description

It was reported that after use the tubes were cracked with a paxgene® blood rna tube.This occurred on 5 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported that the customer had a few paxgene tubes filled with 7-8 ml of blood, that were stored at -80 break/ crack.

• 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: 10414706
• MDR Text Key: 204555243
• Report Number: 9617032-2020-00653
• Device Sequence Number: 1
• Product Code: NTW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• 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: 07/27/2020
• 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