H.6.Investigation summary: no customer samples and no photos were received in support of this complaint from catalog 367841, lot number 2018841.The 100 retentions were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.10 production lot in-house retention tubes were inspected with 0 visible defects.A draw test was performed at the manufacturing site on the 10-production lot in-house retention tubes.All tubes were within specification limits.Bd was unable to confirm the customer¿s indicated failure modes of underfill based on the investigation completed.The defect was not observed in the retention sample testing.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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It was reported that during use with bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes there was a low draw.Patient was re-drawn.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital for schizophrenia on (b)(6) 2023.After admission, he followed the doctor's order for routine blood collection examination.When the nurse punctured the patient with a vacuum blood collection tube, he found that the negative pressure of the vacuum blood collection tube was seriously insufficient, and the blood collection volume was not enough.How to adjust the needle if there is no bleeding in any direction, and the blood collection cannot be completed normally, the nurse immediately discards the blood collection tube, replaces it with another new one, performs a second puncture, and collects blood from the patient again, and the blood collection is successful.This adverse event made the patient's original puncture site red, swollen and painful, and prolonged the patient's waiting time, aggravating anxiety.
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