It was reported when using the bd preset¿ syringe with attached needle there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "after the puncture, the blood flows into the arterial blood sampling device, and after the blood fills the cavity of the arterial blood sampling organ, the blood overflows from the piston.After arterial blood collection, it must be isolated from the air, but blood overflows from the piston of the arterial blood sampling device and cannot be isolated from the air, so the patient is punctured again, causing dissatisfaction among the patients.".
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Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to leakage 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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.
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