The device was not returned for evaluation.A potential failure mode could be " missing components / accessories and/or not according to proper assembly sequence.", a potential root cause for this failure could be "incorrect operation." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.Currently supplied sterile component iodine pouch is unavailable from the supplier, lernapharm, inc.{montreal, quebéc, canada}.This waiver will remove iodine pouches from applicable trays/kits and include instructions to the end users.The instructions for use were found adequate and state the following: "contents: uro-prep¿ tray with: underpad, drape povidone-iodine solution 10cc syringe (prefilled with sterile water) to inflate catheter only.Sterile: contents of inner wrap are sterile unless package is opened or damaged.Directions for use on reverse side.Single use only.Do not resterilize.For urological use only.Specimen container and label walleted, powder-free gloves (2) lubricant packet forceps, prep balls (5) graduated collection container" 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.H3 other text : the device was not returned.
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