It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube, the device experienced underfill or low draw of a tube with blood.This event occurred 60 times.The following information was provided by the initial reporter.The customer stated: the customer complains that only 2-3 ml of blood is drawn into the tube.The blood sample was checked, it is not because of it, but clearly on the tube.In the past 2-3 weeks, 5-6 tubes were affected.The customer complains that the tubes draw only 2-3ml blood.They checked the blood collection, everything was done correctly, the problems are the tubes.During the last 2-3 weeks the problem occurred 5-6 times resp.5-6 tubes were concerned.
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Investigation summary: bd had not received samples or photos for investigation.Therefore, ten (10) retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to underfill 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 notifications.This complaint is unable to be confirmed for the indicated failure mode of underfill based on retention sample testing.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.
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