The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be "drain(s) cannot be connected/become disconnected to a collection device", with a potential root cause of "interface between collection device and drain is inadequate due to material selection or product design".The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this wound drainage product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product family is unknown, the wound drainage product ifus are found to be adequate based on past reviews.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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