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

Catalog Number 762165

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

It was reported when using the bd paxgene® blood dna tubes, the device experienced discolored / abnormal additive form.The following information was provided by the initial reporter.The customer stated: we met with this lot 1021404 of paxgene blood rna ref 762165 at least 5% failure in analysis of degraded rna could we have a different lot with an expiry > to 30/11/2022 please, thank you.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd paxgene® blood dna tubes, the device experienced discolored / abnormal additive form.The following information was provided by the initial reporter.The customer stated: we met with this lot 1021404 of paxgene blood rna ref (b)(4) at least 5% failure in analysis of degraded rna.Could we have a different lot with an expiry > 30/11/2022? please, thank you.

Manufacturer Narrative

H.6.Investigation summary: material #: 762165, lot/batch: #1021404.Bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to erroneous results were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Retain and control tubes performed as expected with regards to fill functionality.The reported issue is generally associated with the rna isolation procedures.If the customer is using the paxgene blood rna kit for purification, it is advised to contact our joint venture partner, (b)(4) customer service for technical assistance.Application support for individual protocols is not available through bd.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 is unable to be confirmed for the indicated failure mode erroneous results.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to erroneous results were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.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.

• Brand Name: BD 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: 14476655
• MDR Text Key: 293356801
• Report Number: 9617032-2022-00509
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 04053727621658
• UDI-Public: 04053727621658
• Combination Product (y/n): N
• Reporter Country Code: FP
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 762165
• Device Lot Number: 1021404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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