BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Model Number 367983 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos for investigation.Therefore, twenty (20) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill 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 underfill.Bd was not able to identify a root cause for the indicated failure mode.
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Event Description
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It was reported when using the bd vacutainer® sst¿ blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred once.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that blood stopped flowing into tube, phlebotomist stated that this was caused due to access issue to the vein.Customer reports that blood stopped flowing into tube.
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Search Alerts/Recalls
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