It was reported that prior to use with bd preset¿ arterial blood collection syringe the unit packaging was open, thus affecting sterility.The following information was provided by the initial reporter, translated from chinese to english: the nurse prepared to use the arterial blood collection device before drawing arterial blood for the patient, and took out a new pack of the product.After checking, it was found that the packaging bag was leaking.The patient himself is treated in the icu, which prolongs the rescue treatment time.
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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 no issues were observed relating to open seal 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 open seal.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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