Investigation summary: "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 clogged cannula 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.".
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It was reported when using the bd preset¿ arterial blood collection syringe the needle was blocked.The following information was provided by the initial reporter.The customer stated: " after the arterial puncture was successful, the blood could not be drawn out, and it was checked that the needle was blocked.Immediately stop using it and replace it with a new one.".
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