Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2174526.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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It was reported that after the bd posiflush¿ normal saline syringe was used, the patient developed numb hands and feet, as well as vomiting and incontinence.The patient became unconscious while using the bathroom and their heart rate dropped, requiring dexamethasone to be injected to wake up.The following information was provided by the initial reporter, translated from chinese: "the patient used flush for picc maintenance.After the bolus injection, the patient complained of hot and numb hands and feet, vomiting (a small amount), and then felt incontinent.When he went to the bathroom, he suddenly became unconscious and his heart rate dropped.Inject dexamethasone to wake up.After waking up, the chief complaint had a pungent smell at that time and was suddenly uncomfortable.Disease: acute promyelocytic leukemia, treated with arsenic trioxide.This time, the patient has just been hospitalized and has not been treated.".
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