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

Catalog Number 762165

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

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 rna tube customer found foreign matter embedded into the cap.The following information was provided by the initial reporter.The customer stated this report is about fm-embedded.Foreign matter was embedded into the cap.

Event Description

It was reported when using the paxgene® blood rna tube customer found foreign matter embedded into the cap.The following information was provided by the initial reporter.The customer stated this report is about fm-embedded.Foreign matter was embedded into the cap.

Manufacturer Narrative

H.6.Investigation summary: bd received 100 samples and 5 photos for investigation.The sample and photos were reviewed and the indicated failure mode for foreign matter with the incident lot was not observed.Additionally, 100 retention samples from bd inventory, were evaluated by visual examination and no issues were observed relating to foreign matter as all samples met specifications.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 foreign matter.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.The following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 11-sept-2023.H3 other text : see h.10.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17720179
• MDR Text Key: 323081372
• Report Number: 9617032-2023-01194
• 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: 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 762165
• Device Lot Number: 2327414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2022
• 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