BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 367844 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: at the moment of sample draw the tubes fill under the limit allowed, which it's required to assure accurate results for diagnostic support.
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Manufacturer Narrative
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H.6.Investigation: no customer samples and 1 photo were received.The photo was visually evaluated showing the amount of specimen drawn into the tubes is below the etched fill line on the tube.As no customer samples were received at the manufacturing site, the investigation was limited.Therefore, 10 production lot in-house retention samples were inspected with 0 visible defects.Additionally, functional testing was performed on the retention samples and the customer's indicated failure mode of underfill was not observed as all tubes were within specification limits.Bd was able to confirm the customer¿s indicated failure mode with the photo provided; however, no samples were returned to be tested and the complaint could not be duplicated in the retention testing.The exact cause for the underfilling of the tube could not be determined.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.The device history records were reviewed on the identified lot with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
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Event Description
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It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: at the moment of sample draw the tubes fill under the limit allowed, which it's required to assure accurate results for diagnostic support.
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