The reported issue was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to ¿defective / contaminated components from supplier".The dhr review could not be performed without a lot number.The product catalog number and lot 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 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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