Investigation summary: bd had not received samples or photos for investigation.Therefore, (b)(4) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to open packaging 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 open packaging.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.
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It was reported when using the bd preset¿ arterial blood collection syringe, the device experienced a damaged, open package seal where sterility is compromised.The following information was provided by the initial reporter.The customer stated: when the patient underwent arterial blood collection in the heart disease department of our hospital on (b)(6) 2021, it was found that the arterial blood collection device was not tightly sealed, so the arterial blood collection device was replaced immediately without causing harm to the patient.
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