The reported event was confirmed.The device had not met specifications, and the product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (inside original packaging), bard silicone channel drain package.The outer packaging was opened, but the inner packaging containing the drain remained sealed.Visual inspection of the sample noted a piece of foreign material measuring 0.2805 inches taped to the exterior of the inner packaging.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warnings: an effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir suction must be maintained in order for the system to function properly.Verify that the system is functioning properly.If the system is not maintained properly, surgical complications, including hematomas, may result." 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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