It was reported when using the bd preset¿ syringe with attached needle there was clogged/blocked cannula.The following information was provided by the initial reporter.The customer stated: "when the arterial blood collector was used to collect blood for the patient, negative pressure of the blood collector was insufficient and there was no blood reflux.When the blood collector was pulled out, the needle was found to be blocked.".
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Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by 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.This complaint is unable to be confirmed for the indicated failure mode clogged cannula.Bd was not able to identify a root cause for the indicated failure mode.
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