The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.A potential root cause for this type of failure could be ¿8.1.2 materials that are contacting the patient¿s intact skin are not biocompatible".However, there was insufficient information to confirm this potential root cause.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - 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.H3 other text : the device was not returned.
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