Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
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It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle would not retract when the button was pressed.As a result, the employee was stuck with the dirty needle and protocol ivd testing was performed.The following information was provided by the initial reporter: "rn used the iv catheter per manufacturers ifu.Safety mechanism was deployed but needle did not retract at all.The nurse pressed the button firmly, multiple times and the needle still did not retract.The button remained pressed down.Was there any use on patient? yes.If so was there any impact or harm due to the reported issue? not with the patient, only the employee.Was there any need for medical treatment or intervention? followed protocol of treating of employee needle stick.".
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