(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 216397.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.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.
|
It was reported that the bd posiflush¿ normal saline syringe plunger was damaged.The following information was provided by the initial reporter, translated from chinese to english: "the patient was admitted to the hospital 3 days after finding a anterior neck mass.On (b)(6) 2021, he underwent general anesthesia for most thyroidectomy.After the operation, he was given symptomatic treatment with fluid infusion.When nurse (b)(6) gave the flushing catheter on (b)(6) 2020, he found the flush's plunger rod was damaged and could not be used, so it was reported to the doctor on duty to immediately replace the flush with a new one and explain to the patient to eliminate doubts, and it did not adversely affect the treatment of the patient.".
|