(b)(4).Results of investigation:one sample and picture was received for evaluation.The sample was submitted to ir scan and it was concluded that the ports from the adapter of product 004081 were exposed to dehp.Pvc may cause the oxygen port to discolor or deform.In conclusion, the deformation could be caused by long term use with pvc connector on the ports of the adapter.No issues were found during the review of internal production records for the lot indicated that could result in the reported condition.At this time there is no evidence that confirms that carefusion operative personnel are contributing to this condition.Internal procedure calls for a visual inspection of this product prior to passing to the next stage.In addition, no issues were found with the materials or design of this product; the materials used for this catalog are validated.Based on the investigation, the most probable cause for the issue reported could be related to the long term use with pvc connector - plasticizers as dehp in flexible pvc may cause the oxygen port to discolor or deform.As an action plan, a modification will be implemented on the instructions for use of this product to include the statement, "up to 30 days" and "caution: devices designed to be attached to this adapter may contain flexible pvc.Plasticizers in flexible pvc may cause the oxygen port to discolor or deform.Periodically inspect the connection and replace product if damage or wear is observed¿.The 004081 adapter should be changed every 30 days.Carefusion will continue to monitor and trend this report.
|