BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 364314 |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: "material #: 364314, lot/batch #: 1197895.Bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to insufficient flow 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 insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".
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Event Description
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It was reported when using the bd preset¿ syringe with attached needle had insufficient blood flow issue, not enough blood has been sucked into the syringe.The following information was provided by the initial reporter.The customer stated: "during using the abg, it found that the abg had insufficient blood flow issue.After entering the blood vessel, blood has returned, but not enough blood has been sucked into the syringe.Considering the lack of negative pressure.The blood was collected successfully after the blood collector was replaced.".
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