The device was not returned for evaluation.A potential failure mode could be ¿sensor wire breaks thermistor cracks or breaks¿ with a potential root cause of ¿sensor wire too weak or thermistor chip too weak¿.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.H11:section a through f - the information provided by bd represents all of 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.H3 other text : the device was not returned.
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