Investigation summary: bd had not received samples, but photos were provided by your facility for investigation.The photos were evaluated and the indicated failure mode for collapsed tubes with the incident lot was observed.Additionally, 100 retention samples were selected from bd inventory for evaluation and upon completion, collapsed tubes were not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.Note that there are potentially varying degrees of tube collapse, based on the temperature and duration of time at elevated temperature.Mildly collapsed tubes will retain vacuum and only show minimal deformation.Mildly collapsed tubes will draw appropriately but may not be able to be processed on laboratory instruments (e.G.May be slightly bowed and no longer fit in a rack).As long as the vacuum is retained and the tube fills appropriately, the tube will function properly.Fully collapsed tubes appear flattened, twisted, and visibly deformed.Fully collapsed tubes retain little or no vacuum and therefore cannot be drawn to an appreciable volume.These tubes are easily identified before use by the healthcare worker, so there is no potential impact to the patient.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
|