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

Catalog Number 762165

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Ingredient or Reagent Problem (2910)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

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 when using the paxgene® blood dna tube, the device experienced erroneous results.This event occurred once.The following information was provided by the initial reporter.The customer stated: genomic contamination or dnase treatment has not worked properly."the blood is being collected at a hospital which collaborate with us, following your instructions (the tube is at room temperature when collected, it is the last tube to be extracted, the tube is inverted 10 times and leaved it at least 2 hours vertically).Then the tubes are sent to us and arrived the next day, we store them at -20ºc vertically and the next day we transfer them to -80ºc.We suspect there is genomic contamination or dnase has not worked properly".

Manufacturer Narrative

The following fields have been updated with corrected information: b.5.Describe event or problem: it was reported when using the paxgene® blood dna tube, the additive was abnormal.This event occurred once.The following information was provided by the initial reporter.The customer stated: genomic contamination or dnase treatment has not worked properly."the blood is being collected at a hospital which collaborate with us, following your instructions (the tube is at room temperature when collected, it is the last tube to be extracted, the tube is inverted 10 times and leaved it at least 2 hours vertically).Then the tubes are sent to us and arrived the next day, we store them at -20ºc vertically and the next day we transfer them to -80ºc.We suspect there is genomic contamination or dnase has not worked properly." h.6 idmrf annex a code: a0302.H.6.Investigation summary: bd had not received samples or photos for evaluation.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.No clinical testing can be performed for this defect.After review by our molecular specialist, it appears that the issue is related to the chemagic kit.The paxgene blood rna tube was designed specifically to work with preanalytix kits and we would not be able to troubleshoot issues with the chemagic kit.No further testing can be done as the product expired april 30, 2021.This complaint is unable to be confirmed for a sample quality issue.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the paxgene® blood dna tube, the additive was abnormal.This event occurred once.The following information was provided by the initial reporter.The customer stated: genomic contamination or dnase treatment has not worked properly."the blood is being collected at a hospital which collaborate with us, following your instructions (the tube is at room temperature when collected, it is the last tube to be extracted, the tube is inverted 10 times and leaved it at least 2 hours vertically).Then the tubes are sent to us and arrived the next day, we store them at -20ºc vertically and the next day we transfer them to -80ºc.We suspect there is genomic contamination or dnase has not worked properly.".

• Brand Name: PAXGENE® BLOOD DNA TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15533534
• MDR Text Key: 303802177
• Report Number: 9617032-2022-00983
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 04053727621658
• UDI-Public: 04053727621658
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 762165
• Device Lot Number: 9233119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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