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 Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: photos were showing a brown coloured rubber stopper, with a small area of black rubber within it.The sample was returned, and confirmed the photographic evidence.Dhr/bhr review: no dhr review was done.Investigation conclusion: the complaint was confirmed upon evaluation of the customer returned sample, and the photos.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure mode with the sample provided, and the photos.Root cause description: the most likely root cause will be poor line clearance by the stopper manufacturer; a pellet of black rubber being mixed in with the brown.It is a cosmetic defect which would not affect the efficacy of the finished product.Based on an evaluation of severity and frequency, it was determined that no corrective action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for monitoring of current trends.

Event Description

It was reported that foreign matter was found in the cap of 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: 7455858
• MDR Text Key: 106605405
• Report Number: 9617032-2018-00588
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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
• Date Manufacturer Received: 03/07/2017
• 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