The reported event is inconclusive because no sample was returned and further investigation was not conclusive.Though a specific cause cannot be determined, based on the risk document potential root causes for this event could be, multiple tally in the station during the label printing, typo error.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: warning.After use this product may be a potential biohazard.Handle and dispose of in accordance with medical practice and with applicable laws and regulations.Single use.Do not use if package is opened.Do not resterlize.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device was not returned.
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It was reported that the surgeon opened the package of the product and found that the size of the ureteral stent was 4.7 fr, which was inconsistent with that on the packaging label.The size on the label of the outer package was 6 fr, 26 cm.The product was therefore replaced and another one was used.The health care professional raised doubt about the quality of bd products, significantly affecting the brand¿s image and worried about the reoccurrence of similar event.
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