The reported event was found to be inconclusive.The photo sample received was not adequate to perform further investigation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿[shape, configuration and principles] bard® i.C.Foley tray b consists of a balloon catheter, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, waterproof sheet, tweezers, gauze pads, cotton balls, and vinyl gloves.There are two types of catheters, two way and three way, and several types of closed drainage bags.The catheter and/or bag included in the tray will depend on the product. balloon catheter: natural rubber latex available in sizes 8 to 24 every 2fr" 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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