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

Catalog Number 762165

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the tube concerned was returned by the customer, and 2 small black fms could be seen suspended in the additive.Photographs were also attached, showing the fms at various magnifications.Visual examination of the 200 retained samples from the implicated lot number did not identify any instances of fm.Dhr/bhr review: a review of the dhr did not identify any issues associated with the reported defect.Investigation conclusion: evaluation of the returned sample and review of the attached photos confirmed the reported defect.Confirmed.Bd was able to duplicate or confirm the customer¿s indicated failure mode with the sample and photos provided.Root cause description: the most likely root cause of the fm is that it entered the tube in the period between filling with additive and evacuation /stoppering.Unfortunately, the origin of the fm is not known as the constituents could not be identified.Much work has been done since this tube was manufactured in an effort to limit the possibility of fm being able to enter the tubes.This has resulted in a significant reduction in complaints of this nature.The next step in this work is to introduce new covers for the trolleys used to transport open tubes through processing.

Event Description

It was reported that foreign matter was found inside a paxgene® blood rna tube before use.There was report of injury or medical interventions.

• Brand Name: PAXGENE® BLOOD RNA TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7455852
• MDR Text Key: 106726260
• Report Number: 9617032-2018-00523
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial
• Report Date: 04/16/2018

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 Expiration Date: 03/31/2018
• Device Catalogue Number: 762165
• Device Lot Number: 6194598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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