BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 364314 |
Device Problems
Inability to Auto-Fill (1044); Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: "material #: 364314.Lot/batch #: 1299054.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 colored water, and no issues were observed relating to incorrect stopper placement nor 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 modes incorrect stopper placement or insufficient 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¿ arterial blood collection syringe customer found the device was in wrong position, and insufficient blood flow issue.The following information was provided by the initial reporter.The customer stated: "before use, it found that the abg has plunger stopper wrong position in syringe issue and insufficient blood flow issue.".
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Event Description
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It was reported when using the bd preset¿ arterial blood collection syringe customer found the device was in wrong position, and insufficient blood flow issue.The following information was provided by the initial reporter.The customer stated: "before use, it found that the abg has plunger stopper wrong position in syringe issue and insufficient blood flow issue.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but 1 photo of an unused syringe was provided for investigation.The photo was reviewed and the indicated failure modes for incorrect stopper position and insufficient blood flow with the incident lot were not observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with colored water, and no issues were observed relating to incorrect stopper position and insufficient blood 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 modes incorrect stopper position and 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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