BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 364314 |
Device Problems
Fluid/Blood Leak (1250); Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd preset¿ arterial blood collection syringe, blood flow reaches 0.5ml, the piston of the arterial blood collection device cannot slide by itself, so 1ml blood can be extracted manually, and blood leakage occurred.The following information was provided by the initial reporter.The customer stated: ¿when the arterial blood collection device is connected to the blood collection needle, blood is drawn smoothly.When the arterial blood flow reaches 0.5ml, the piston of the arterial blood collection device cannot slide by itself, so 1ml blood can be extracted manually, and blood leakage occurred.".
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Manufacturer Narrative
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Investigation summary: "material #: 364314, lot/batch #: 1162363.Bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional testing, each used to draw water, and no issues were observed relating to difficult to move plunger or leakage 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 difficult to move plunger and leakage.Bd was not able to identify a root cause for the indicated failure modes.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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Search Alerts/Recalls
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