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

Catalog Number 762174

Device Problem Leak/Splash (1354)

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

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown.Device manufacture date: unknown.There are multiple bd locations where this device may have been manufactured.Once we have ascertained where the device was manufactured a supplemental report will filed.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 the secondary hemogard closures are not fitting into the paxgene® blood rna tube.

Event Description

It was reported that the secondary hemogard closures are not fitting into the paxgene® blood rna tube.

Manufacturer Narrative

The corrections are as follows: medical device manufacturer: becton, dickinson and company (bd).Manufacturing location: becton, dickinson and company (bd).

Event Description

It was reported that the secondary hemogard closures are not fitting into the paxgene® blood rna tube.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.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.

• Brand Name: PAXGENE® BLOOD RNA TUBE
• Type of Device: RNA BLOOD COLLECTION TUBES
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth NJ 07417
• MDR Report Key: 8191639
• MDR Text Key: 131333985
• Report Number: 2243072-2018-01836
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 762174
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/07/2018; 12/07/2018
• Supplement Dates FDA Received: 01/09/2019; 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other