It was reported that during use with bd preset¿ arterial blood collection syringe the plunger was discovered to be broken.The following information was provided by the initial reporter, translated from chinese to english: on the morning of (b)(6), 2023, when the nurse pre-collected blood from the patient's artery, the plunger stopper broken and was replaced immediately.
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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 visual examination and no issues were observed relating to damaged plunger stopper 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 plunger stopper.Bd was not able to identify a root cause for the indicated failure mode.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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