There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5216788.Medical device expiration date: 2018-07-3.1 device manufacture date: 2015-08-04.Medical device lot #: 7031860.Medical device expiration date: 2020-01-31.Device manufacture date: 2017-02-01.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Udi: (b)(4).
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Investigation: lot analysis: device/batch history record review: yes, reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr).This complaint is an mdr.Dhr review was performed on the following lot numbers: 5216788 ¿ the lot number was packaged on packaging line 11 from august 12, 2015 thru august 12, 2015.7031860 ¿ the lot number was packaged on packaging line 11 from february 16, 2017 thru february 16, 2017.5300881 ¿ the lot number was packaged on packaging line 11 from january 8, 2016 thru january 9, 2016.Per review of the dhr¿s it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Set-up and in process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Visual analysis: observations and testing: received one unused iag/bc 16ga unit in partially opened package from the lot number 5216788.Received one unused iag/bc 16ga unit in partially opened package from the lot number 7031860.Received one unused iag/bc 16ga unit in partially opened package from the lot number 5300881.Visual/microscopic examination: 5216788: the package was partially opened at both ends of the blister pack.7031860: the package was partially opened at both ends of the blister pack.5300881: the package was partially opened at both ends of the blister pack.The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition the paper top web of the returned unit was analyzed under uv light.The glue used to seal the top and bottom webs is uv fluorescent.The analysis revealed an adequate of top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were looked at during the investigation.Investigation samples(s) meet manufacturing specifications: yes; the returned units provided for evaluation for this incident met the manufacturing specification requirements.Conclusions: the defect of package damage/defective/other, as stated in the subject of the pir was confirmed with the returned unit.Even though the packages came partially opened, all the processes characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification.No anomalies were found.Did the evaluation confirm the customer's experience with the bd product? yes; the customer experience was confirmed based on the evaluation that was performed on the returned unit.Were we able to reproduce the customer's experience with the bd product? no; it was not necessary to achieve reproduction of the customer¿s experience, as the defect was confirmed.Was the device used for treatment or diagnosis? treatment.Root cause: relationship of device to the reported incident: indeterminate.Comment: although the samples were received with packages opened / partially peeled, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.Corrective action / capa #: capa (b)(4) has been opened to investigate the package open seal defects and implement corrective actions.Other actions taken (if applicable): packaging operators are responsible to verify package integrity, including the verification that the packages are adequately sealed.In addition, product quality is evaluated during the manufacturing and packaging process with prescribed attributes inspections.These inspections are performed by operators to ensure any gross process changes are identified.If defects are observed, disposition of the product, root cause and corrective action(s) are applied according to the quality control plan.
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