The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer reported a uvc fragment was incidentally identified in the nicu patient¿s aorta on imaging.The rn removed the catheter and noted it was not intact.The markings indicated there was 15cm missing.The uvc was inserted at another hospital.Additional information received stated, per staff interview, the standard process to remove a uvc is to clip the suture and then pull gently and slowly on the catheter for removal.The rn didn't notice anything unusual about removing the catheter following this process.The patient was transferred to an out of network facility and the retained arterial catheter was removed by the ir team.There were no identified complications caused by the retained arterial catheter.
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