Date of birth: only the patients age was provided, therefore a default date of birth has been listed.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.Investigation conclusion: the defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced a defective catheter tip.The following information was provided by the initial reporter: material is requested for puncture, at the time of puncture the tip got opened.After the event that was during use, the device was changed for a new one.Because the catheter was contaminated it was discarded and they have no photos.
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