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

Model Number 762165

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

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

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: bd had not received samples, but 5 photos were provided for investigation.The photos were reviewed and the indicated failure mode for underfill was observed.Additionally, 20 retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not observed as all 20 retention samples drew within specification.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode for underfill based on the provided photos.Bd was not able to identify a root cause for the indicated failure mode.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 underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: update (b)(6) 2021 we had a new nurse covering vacation and she did not drain the hose before drawing the blood from the paxgene tube.It just coincided with the tube box change.It had never happened to us before.Rcc-if i have understood it well and to confirm, do you mean that the defect is due to a human error of the nurse and not a defect on the part of the tubes? c-exactly.Apparently it was human error.I attach a new photo, where we do the correct purging of the air from the hose, before using the tube.We were used to seeing tubes a little fuller, but checking the volume, it seems that we managed to extract just over 2 ml from the vacuum.It is not 2.5ml, but we believe that that is enough for the test.Apparently the vacuum is not enough to fill the tubes (as they are normally filled).

• 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: 12550594
• MDR Text Key: 274484903
• Report Number: 9617032-2021-01012
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082150
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 762165
• Device Catalogue Number: 762165
• Device Lot Number: 0300075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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