BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 364314 |
Device Problems
Volume Accuracy Problem (1675); Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Investigation summary: "material #: 364314.Lot/batch #: 2038088.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 used to draw water, and no issues were observed relating to insufficient flow or air bubbles 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 modes insufficient blood flow and air bubbles.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¿ arterial blood collection syringe it had insufficient blood flow issue , with a large number of bubbles.The following information was provided by the initial reporter.The customer stated: ¿during using, it was found that the abg had insufficient blood flow issue, with a large number of bubbles, resulting in blood gas results.¿.
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