BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 364314 |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd preset¿ syringe with attached needle there was insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: "the nurse followed the doctor's advice to collect arterial blood.After entering the blood vessel, blood returned, but the blood collection device had no negative pressure, and the arterial blood could not enter the blood collection device by itself.".
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos for investigation.Therefore, 5 retention samples from bd inventory were evaluated by visual examination and functional testing, each used to draw colored 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.
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Search Alerts/Recalls
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