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.
|
|
Search Alerts/Recalls
|