E.1.Initial reporter phone #: (b)(6).H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to damaged 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 damaged cannula.Bd was not able to identify a root cause for the indicated failure mode.
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It was reported that prior to use with bd preset¿ arterial blood collection syringe the cannula was discovered to be damaged.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, when the nurse gave the patient arterial blood gas blood collection according to the doctor's advice, she opened the blood collection needle and found that the cannula was damaged, so she replaced the blood collection needle immediately.
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