H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was not returned for evaluation, therefore, the investigation is inconclusive for the alleged leak and material split, cut, or torn.The product catalog number was revised and the malfunction was reassessed and the trending code 1354 - leak was added.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.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.
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