The reported event was confirmed.Visual inspection noted two photo samples were received.Visual evaluation noted that both of the photos show a portion of the tubing that has cracking throughout with the device leaking out.Although the product code is unknown and therefore specifications are unknown, this is considered to be out of specification for fecal containment devices.The photos do not show the balloon of the device, and therefore it is unknown if the device was able to inflate.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be material too thin.The product was used for treatment purposes.The product was influenced by the reported failure.The product did not meet specifications.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the fecal management system ifus were 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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